Clinical Research & Trials

100510 / Duke University / Consolidation RT in DLBcL / Louis Constine

Lead Researcher: Louis Constine

This phase II study will evaluate whether a reduction in radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity . Hypothesis: The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET-CT scan following rituximab - containing chemotherapy.

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4AP/ UGUP18139/ Ahmed Ghazi

Lead Researcher: Ahmed Ghazi

To evaluate the role of 4-aminopyridine (4-AP) on the course of recovery after peripheral nerve traction and/or crush injury. This study aims to test the hypothesis that 4-aminopyridine speeds the often slow and unpredictable recovery after peripheral nerve traction and/or crush injuries.

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A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)

This is a global, randomized, double-blind, controlled study to evaluate the efficacy of bemarituzumab (FPA144) + mFOLFOX6 versus placebo + mFOLFOX6 in patients with FGFR2 selected Gastric Cancer (as determined by prospective IHC FGFR2b overexpression and/or a ctDNA blood assay demonstrating FGFR2 gene amplification)

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A Study of TAK-071 in People With Parkinson Disease

Lead Researcher: Karlo Lizarraga mendoza

It is hoped that TAK-071 will help people with Parkinson's disease to walk with better balance. The main aim of the study is to check if there is a difference in how participants walk after treatment with TAK-071. Another aim is to see if it improves how participants think and remember. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 groups by chance. Both groups will have 2 treatments but in a different order. The treatments are TAK-071 tablets or placebo. In this study, a placebo will look like the TAK-071 but will not have any medicine in it. One group will take TAK-071 for 6 weeks, have at least a 3-week break, then take a placebo for 6 weeks. The other group will take a placebo for 6 weeks, have at least a 3-week break, then take TAK-071 for 6 weeks. The participants will not know the order of their 2 treatments, nor will their study doctors. This is to help make sure the results are more reliable. The participants will visit the clinic at the beginning and end of each treatment for a check-up. 14 days after the 2nd treatment, clinic staff will telephone the participants for a final check-up.

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A Trial of the Efficacy and Safety of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures

Lead Researcher: Trenton Tollefson

The purpose of this study is to assess the efficacy, safety, and tolerability profile of CVL-865 as adjunctive treatment in participants with drug-resistant focal onset seizures.

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A041703 / CLEU19006 / O'Dwyer, Kristen

Lead Researcher: Kristen O'Dwyer

This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back, or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin and blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

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A071801 / RBRT19176 / SRS for Resected Metastatic Brain Disease / Usuki

Lead Researcher: Kenneth Usuki

This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body and has been removed by surgery. Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.

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A081801 / RLUN20119 / ALCHEMIST-IO (ACCIO) / Yuhchyau Chen

Lead Researcher: Yuhchyau Chen

This phase III ALCHEMIST trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB IIIA or IIIB non-small cell lung cancer.

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A151216 ALCHEMIST Screening Protocol

Lead Researcher: Yuhchyau Chen

This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

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A5379: B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

Lead Researcher: Sonal Munsiff

The purpose of this study is to evaluate response to and safety of the HBV vaccine HEPLISAV-B in two study populations living with HIV: prior HBV vaccine recipients who are deemed non-responders and individuals who are naïve to HBV vaccination. To be eligible you must have the following: - HIV-1 infection - On current HIV-1 antiretroviral therapy (ART) - CD4+ T-cell count ≥100 cells/mm^3 - HIV-1 RNA <1000 copies/mL

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A5383: A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With HIV-1 and Asymptomatic Cytomegalovirus

Lead Researcher: Sonal Munsiff

This study will determine if the drug, letermovir, is an anti-inflammatory in adults with HIV and asymptomatic cytomegalovirus (CMV) who are on anti-HIV medications and whose HIV is suppressed. Participants will be randomly assigned to receive either letermovir once daily or no anti-CMV treatment, for 48 weeks. There will be treatment provided in this study. Letermovir is a pill given by mouth once a day that is FDA-approved to prevent CMV disease. There are two study treatment groups. You will have a 50/50 chance of going into one of the two groups. Participants in one group will get letermovir and participants in the other group will not get any additional medications. To Enter the Study, the following must be true about you: • HIV positive, ≥40 years of age • On continuous anti-HIV medications for at least 48 months with no interruptions >7 days • At least 48 months of undetectable viral loads, although a one-time, low-level viral load is OK • Have not made significant change in HIV medication in the past 12 weeks, or plan to make changes during study participation • While people with any CD4 count are eligible, the study is particularly interested in recruiting people with low CD4 counts (i.e., <350 cells/mm3)

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A5391: Doravirine for Persons with Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)

Lead Researcher: Sonal Munsiff

Weight gain after starting antiretroviral therapy (ART) is common, but recent studies have found that some people living with HIV who are taking an integrase strand transfer inhibitor (INSTI) combined with tenofovir alafenamide/emtricitabine (TAF/FTC) or tenofovir alafenamide/lamivudine (TAF/3TC) may gain more weight than people taking other drug combinations. A rising number people living with HIV are overweight or obese. This may increase the risk for diabetes, heart disease and stroke. Researchers are looking to see if people living with HIV who have gained a significant amount of weight after starting or switching therapy, can either reduce their rate of weight gain over time or even lose weight with a change to a different ART regimen. This study will include participants who are living with HIV-1, who have been virally suppressed for > 48 weeks on a regimen consisting of an INSTI and TAF/FTC or TAF/3TC and who have experienced > 10% weight gain since the initiation of this ART regimen.

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ADVANCED-1/ IGUB21083 / Messing

Lead Researcher: Edward Messing

This study is an open-label dose escalation study (Phase 1a) to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002 in adults unable to obtain intravesical Bacillus Calmette-Guérin (BCG), adults who have received at least one dose of intravesical BCG or adults who have received at least one dose of intravesical chemotherapy. Dosing will start in subjects with HGTa or CIS NMIBC to include a minimum of 1 dosing cohort and a maximum of 3 total dosing cohorts. All subjects will receive 6 weeks of treatment at a fixed volume with varying doses levels.

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Assessment of Patients with Brain Tumors, Ages 65+

Lead Researcher: Andrea Wasilewski

The purpose of this study is to collect information about the physical function, thinking, independence, social support, and medications of older patients with brain tumors in order to develop more specialized treatments and support for that population. Inclusion Criteria: Age 65 or older of any race, ethnicity, or gender; Pathologically confirmed glioblastoma or anaplastic astrocytoma; Have not started radiation or chemotherapy for brain tumor treatment

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Cancer (Geriatric): Cognitive Rehabilitation For At-Risk Older Cancer Patients Receiving Chemotherapy: A Pilot Study Evaluating Feasibility And Impact

Lead Researcher: Allison Magnuson

In Phase I all subjects will receive cognitive rehabilitation intervention which includes, workshops and at-home computer-based cognitive training. In the phase II portion of the study, depending on the group you are assigned, you may receive cognitive rehabilitation intervention or usual care. This will help researchers develop a doable approach to cognitive rehabilitation and see if it helps reduce the risk of developing progressive cognitive impairments which is a common side effect of chemotherapy.

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CBMT11074 / NMDP 10-CBA / Jane Liesveld

Lead Researcher: Jane Liesveld

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

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CBRS18119 / S1706 / Ajay Dhakal

Lead Researcher: Ajay Dhakal

This phase II trial studies how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.

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CBRS20023, Dhakal, EA1181, Breast Cancer, Paclitaxel Docetaxel Trastuzumab Pertuzumab Nab-paclitaxel

Lead Researcher: Ajay Dhakal

This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.

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CBRS21001 / A011801 / Dhakal

Lead Researcher: Ajay Dhakal

This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

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CBRT20074 / A071701 / NImish Mohile

Lead Researcher: Nimish Mohile

This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK or PI3K. Medications that target these genes such as abemaciclib, paxalisib, and entrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation.

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Cervical Cancer/ Emergency Department/ UCCS20125/ David Adler

Lead Researcher: David Adler

Invasive cervical cancer is preventable with adequate screening but screening rates are considerably below national goals. Emergency departments care for a disproportionate number of women who are not up to date with recommended cervical cancer screening. This study will evaluate the effectiveness of a mobile technology based behavioral intervention (using text messaging prompts) to increase cervical cancer screening uptake among emergency department patients.

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CGIP19127 / A021602 / Aram Hezel

Lead Researcher: Aram Hezel

This randomized phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that have spread to other places in the body (advanced). Cabozantinib is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.

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CGIP20076, Zittel, EA2186, 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan

Lead Researcher: Jason Zittel

This phase II trial compares two treatment combinations: gemcitabine hydrochloride and nab-paclitaxel, or fluorouracil, leucovorin calcium, and liposomal irinotecan in older patients with pancreatic cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as gemcitabine hydrochloride, nab-paclitaxel, fluorouracil, leucovorin calcium, and liposomal irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study may help doctors find out which treatment combination is better at prolonging life in older patients with metastatic pancreatic cancer.

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CGIP20087 / A021806 / Richard Dunne

Lead Researcher: Richard Dunne

This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

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CGUB19067 / S1600 / William Tabayoyong

Lead Researcher: William Tabayoyong

This phase III trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.

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CGUK20101 / A031704 / Deepak Sahasrabudhe

Lead Researcher: Deepak Sahasrabudhe

This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.

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CGUP18150 / S1802 / Chunkit Fung

Lead Researcher: Chunkit Fung

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

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CGYC16057 / NRG-GY006 / Richard Moore

Lead Researcher: Richard Moore

This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

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CGYE19140 / NRG-GY018 / Richard Moore

Lead Researcher: Richard Moore

This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.

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CGYE21013 / NRG-GY020 / Richard Moore

Lead Researcher: Richard Moore

This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of pembrolizumab to radiation treatment may be more effective than radiation treatment alone in reducing cancer recurrence.

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CGYM19142 / NRG-GY019 / Richard Moore

Lead Researcher: Richard Moore

This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.

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CGYN18151 / NRG-GY012 / Richard Moore

Lead Researcher: Richard Moore

This phase II trial studies the effects of the combination of olaparib and durvalumab, cediranib and durvalumab, olaparib and capivasertib, and cediranib alone in treating patients with endometrial cancer that has come back (recurrent) or does not respond to treatment (refractory). Olaparib, cediranib, and capivasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Testing the combinations may lower the chance of endometrial cancer growing or spreading compared to usual care.

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CGYO20085 / NRG-CC008 / Richard Moore

Lead Researcher: Richard Moore

This trial studies how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for women with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.

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Challenges associated with vision loss

Lead Researcher: Steven Silverstein

You will be asked to complete 3 surveys online that will take about a total of 25-30 minutes to complete. The surveys will ask questions about how you have adjusted to your vision loss, as well as the effects of vision loss on your mood, anxiety, and quality of life.

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CHAN19107 / EA3161 / Megan Baumgart

Lead Researcher: Megan Baumgart

This phase III trials studies whether maintenance immunotherapy (nivolumab) following definitive treatment with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (time being alive) and progression-free survival (time being alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive oropharynx cancer (throat cancer) that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in treating patients with HPV positive oropharyngeal cancer.

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Chronic Pain Study

Lead Researcher: Paul Geha

This study will use subjective rating methods, computer-based games, and brain imaging to study the characteristics of chronic pain and brain processes that cause them. By so doing we hope to obtain new information and understanding of chronic pain across multiple conditions. Eligibility: Ages 18-65; in generally stable health; diagnosed with a pain condition: Chronic back pain (CBP), Osteoarthritis of the knee (OAk), Temporomandibular joint disorder(TMJ), Complex regional pain syndrome (CRPS), or Pelvic Pain (PP).

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CLEU19017 / S1712 / Kristen O'Dwyer

Lead Researcher: Kristen O'Dwyer

This randomized phase II trial studies how well ruxolitinib phosphate, and bosutnib, dasatinib, imatinib or nilotinib, work in treating patients with chronic myeloid leukemia. Chronic myeloid leukemia cells produce a protein called BCR-ABL. The BCR-ABL protein helps chronic myeloid leukemia cells to grow and divide. Tyrosine kinase inhibitors, such as bosutinib, dasatinib, and nilotinib, stop the BCR-ABL protein from working, which helps to reduce the amount of chronic myeloid leukemia cells in the body. Ruxolitinib is a different type of drug that helps to stop the body from making substances called growth factors. Chronic myeloid leukemia cells need growth factors to grow and divide. The addition of ruxolitinib to the tyrosine kinase inhibitor may or may not help reduce the amount of chronic myeloid leukemia cells in the body.

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CLEU20105/ S1905/ Kristen O'Dwyer

Lead Researcher: Kristen O'Dwyer

This phase II trial studies how well OBI-3424 works in treating patients with T-cell acute lymphoblastic leukemia that has come back (relapsed) or does not response to treatment (refractory). Drugs used in chemotherapy, such as OBI-3424, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. OBI-3424 may reduce the amount of leukemia in the body.

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CLEU20136 / EA9181 / O'Dwyer

Lead Researcher: Kristen O'Dwyer

This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.

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CLUN19026 / LUNGMAP / Megan Baumgart

Lead Researcher: Megan Baumgart

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

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CLUN20055 / EA5181 / Arpan Patel, MD

Lead Researcher: Arpan Patel

This phase III trial studies how well an antibody (durvalumab) with chemotherapy and radiation therapy (chemoradiation) works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if adding durvalumab to standard chemoradiation followed by additional durvalumab can extend patients life and/or prevent the tumor from coming back compared to the usual approach of chemoradiation alone followed by durvalumab.

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CLUN21035 / S1900E / Baumgart

Lead Researcher: Megan Baumgart

This phase II Lung-MAP treatment trial studies the effect of AMG 510 in treating non-squamous non-small cell lung cancer that is stage IV or has come back (recurrent) and has a specific mutation in the KRAS gene, known as KRAS G12C. Mutations in this gene may cause the cancer to grow. AMG 510, a targeted treatment against the KRAS G12C mutation, may help stop the growth of tumor cells.

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CLYM17103 / EA4151 / Paul Barr

Lead Researcher: Paul Barr

This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.

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CLYM19112 / S1826 / Jonathan Friedberg

Lead Researcher: Jonathan Friedberg

This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.

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CLYM19123 / AALL1731 / Mullen

Lead Researcher: Craig Mullen

This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better than combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.

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CLYM19150 / EA4181 / Reagan

Lead Researcher: Patrick Reagan

This phase II trial compares three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib and studies how well they work in treating patients with newly diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This study is being done to find out if one the drug combinations of bendamustine, rituximab, high dose cytarabine, and acalabrutinib is better or worse than the usual approach for mantle cell lymphoma.

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CLYM20151 / S1925 / Barr

Lead Researcher: Paul Barr

This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.

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CMLT20100 / S1823 / Chunkit Fung

Lead Researcher: Chunkit Fung

This trial studies whether the blood marker micro ribonucleic acid (miRNA) 371 can predict the chance of cancer returning in patients with germ cell cancers. Studying samples of blood from patients with germ cell cancers in the laboratory may help doctors predict how likely the cancer will come back.

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CMMY19113 / S1803 / Brea Lipe

Lead Researcher: Brea Lipe

Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.

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COVID-19 Vaccine Studies

Lead Researcher: Ann Falsey

URMC is studying several variations of a COVID-19 vaccine. Compensation: $500-$900. Participation Requirements: Age 18+; Have not been infected with COVID-19. To volunteer, take our survey to find out if you qualify: https://redcap.urmc.rochester.edu/redcap/surveys/?s=XHH9MC8RMK

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Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants

Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo

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Developmental Impact of NICU Exposures (DINE)

Lead Researcher: Gloria Pryhuber

Entry into the DINE study requires prior enrollment in the Prematurity and Respiratory Outcomes Program (PROP) or the Impact of Respiratory Virus Infections and Bacterial Microbiome Shifts/PRISM study. If you have not participated in these studies in the past you will not be eligible for this trial. The DINE study will test the hypothesis that potentially avoidable NICU-based exposures contribute to the neuro-cognitive and somatic impairments prevalent among NICU graduates. This hypothesis is drawn from the documented impact of phthalate exposure on early development in term-born children, and the acknowledged presence of these toxic chemicals in the NICU. Third trimester in utero exposure to phthalates have been linked to poorer childhood performance in cognition, motor function, attention, hyperactivity and social behavior. Phthalate exposure is also associated with altered onset of puberty and asthma. The multi-site cohort and approach will clarify the role of NICU-based phthalate exposure on high-prevalence clinical outcomes.

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DRO2001 / RGUP20045 / Prostate HDR Brachy / Hong Zhang

Lead Researcher: Hong Zhang

The purpose of this study is to learn more about what effects the use of high-dose-rate (HDR) brachytherapy on prostate cancer recurrence, seen by AXUMIN PET scan, has on prostate cancer.

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DRO2005 / RHAN20083 / ALTENS / Michael Cummings

Lead Researcher: Michael Cummings

The purpose of this study would like to learn if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth.

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DRO70001 / Cognitive Changes in Patients Receiving Partial Brain Radiation / Sara Hardy

Lead Researcher: Sara Hardy

Cranial radiation therapy (RT), commonly used to treat benign and malignant brain tumors, can lead to cognitive impairments in domains not related to neuroanatomic structures directly impacted by the tumor. The study will prospectively enroll 75 patients with benign and low-grade brain tumors who will undergo partial brain RT, with either conventionally fractionated or hypofractionated schedules. Subjects will receive MRI scans at baseline, 6 months, and 12 months. Given the role of the limbic system in key cognitive functions affected by RT, researchers have a particular interest in characterizing MRI changes in the limbic system and thalamus in relation to memory and related processes. Specific Aims: To examine objective neurocognitive changes over time. The investigators hypothesize that they will see RT-induced neurocognitive impairment in up to 50% of patients after cranial RT. To examine changes in brain tissue (via MRI) induced by off-target RT in patients with benign and low-grade brain tumors. The investigators specifically hypothesize that comapping of RT dose and MRI changes in the thalamus and limbic system (i.e., thalamic nuclei, hippocampus, fornix, hypothalamus/mammillary bodies, limbic lobe, cingulum) will be most distorted by off-target RT. To examine the relationship between MRI changes for key neuroanatomic structures identified in Aim 1 with objective neurocognitive testing. The investigators hypothesize that cognitive decline will be correlated with damage revealed by MRI to limbic and thalamic structures. This research will help to define which neuroanatomic structures are most at risk from RT-induced damage and will help ultimately establish new dose constraint guidelines for important structures to improve cognitive outcomes.

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DRO72835 / ULUN18075 / Lung 3 vs 5 Fx SBRT / Deepinder Singh

Lead Researcher: Deepinder Singh

This study's goal is to find out if the kind of side effects people experience from radiation is different depending on the schedule of their radiation treatment. Patients will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation. After patients complete radiation treatment, they will follow up with their radiation oncologist.

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Dry Mouth Study

Lead Researcher: Szilvia Arany

The purpose of the study is to study dry mouth as the frequent side effect of certain medications. Dry mouth can lead to tooth decay and cavities, damage to the gums of your mouth, and problems with speaking and swallowing. There is not a lot known about how certain medications can affect oral health. This study will explore how genetic variations and certain medications play a role in the development of dry mouth. Inclusion criteria: age between 45 and 64 years; usage of at least one medication that could cause dry mouth

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EA2174 / RGIE21010 / Esophageal and Gastroesophageal Junction / Haoming Qiu

Lead Researcher: Haoming Qiu

This phase II/III trial studies the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy might be more effective in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.

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EA2182 / RGIC19164 / DECREASE / Haoming Qiu

Lead Researcher: Haoming Qiu

This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.

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Eliminating Monitor Overuse Trial (EMO Trial)

Lead Researcher: Lauren Solan

The purpose of this study is to identify the optimal deimplementation strategies for an overused practice: continuous pulse oximetry monitoring of children hospitalized with bronchiolitis who are not receiving supplemental oxygen.

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Epilepsy Treatment Study (Kayak Study)

Lead Researcher: Inna Hughes

The study, known as the Kayak Study, looks at how the investigational drug affects the symptoms, quality of life, severity of seizures, and frequency of seizures when compared to a placebo (inactive drug) in individuals 2-21 years of age diagnosed with SCN8A-DEE.

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Ethnic Differences in Iron Absorption (FeGenes)

Lead Researcher: Eva Pressman

Iron is a very important nutrient in our diet. Many individuals do not have enough iron and can develop anemia, while other individuals are at an increased risk of accumulating excess iron in their bodies. This study aims to: (1) investigate population differences in iron absorption between East Asian and Northern European adults, (2) assess hormonal and biochemical determinants of iron absorption between East Asian and Northern European adults, and (3) investigate genetic contributions to iron absorption, iron status and iron regulatory hormones between East Asian and Northern European adults. Inclusion Criteria: Healthy adults of Northern European or East Asian ancestry // Aged 18 - 50 years old // Non-smoking // Not pregnant or lactating​ // Not a current blood donor

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Evaluation of multiple biomarkers to estimate risk of cancer in gynecology patients presenting with a pelvic mass

Lead Researcher: Richard Moore

The purpose of this study is to validate and refine a technology that can help physicians determine whether an abnormal pelvic mass in women is benign (non-cancerous) or malignant (cancerous) using a blood test. The specific technology is called ParsortixTM PC1 system, a semi-automated system capable of capturing and harvesting rare cells for subsequent analysis from blood based on the size and deformability of the cells.

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Expanded Access Program of Ponatinib

This protocol will allow expanded access of ponatinib to patients ≥18 years with chronic myeloid leukemia (CML) any phase or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) who have failed all available treatment options.

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Feasibility of the Memory and Attention Adaptation-Training Geriatrics Intervention in Older Cancer Survivors With Mild Cognitive Impairment

Lead Researcher: Allison Magnuson

Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive behavioral therapy-based intervention tailored specifically for older adults and the feasibility of MAAT-G in older cancer survivors with Mild Cognitive Impairment (MCI) is being evaluated.

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GA-CARES/ Jacob Nadler/ SMLT1799

Lead Researcher: Jacob Nadler

This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane, or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.

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Hematopoietic Stem Cell Transplantation: Evaluation of Investigational Cryopreserved Cord Blood Units (CBUs)

Lead Researcher: Omar Aljitawi

The purpose of this study is to document and evaluate all problems that may occur with the use of investigational cord blood units. This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems. The cord blood units in this study have been collected, processed, tested and stored by the National Cord Blood Program and meet the criteria for transplantation as approved by NetCord-FACT (Foundation for the Accreditation of Cellular Therapy).

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Hydrocortisone for premature babies

Lead Researcher: Carl D'angio

The Hydrocortisone and Extubation study will test if giving hydrocortisone for 10 days improves survival for premature infants who have a breathing tube. Infants will either receive hydrocortisone or placebo.

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IBMT19101 / KTE-C19-104 / KITE Zuma 4 / Kristen O'Dwyer

Lead Researcher: Kristen O'Dwyer

The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL).

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IBRS19007 / FLEX Registry / Ajay Dhakal

Lead Researcher: Ajay Dhakal

The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.

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IBRS20071 / J2J-MC-JZLA (b) / Ajay Dhakal

Lead Researcher: Ajay Dhakal

The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.

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IBRT20063 / EF-32 / Nimish Mohile

Lead Researcher: Nimish Mohile

To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

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IGUP20133 / Van Veldhuizen / ARC-6

Lead Researcher: Peter Van Veldhuizen

This is a Phase 1b/2, open-label, multicenter platform trial to evaluate the antitumor activity and safety of etrumadenant (AB928)-based combination therapy in participants with metastatic castrate resistant prostate cancer (mCRPC).

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IGYO20108 / EP0057-201 / Richard Moore

Lead Researcher: Richard Moore

EP0057-201 is a Phase 2A/B adaptive design study. Phase 2A will test EP0057 in combination with Olaparib and Phase 2B, the randomised part of the study, will test EP0057 in combination with Olaparib against SOC chemotherapy. When EP0057 is combined with Olaparib, it is envisaged that the combination should improve therapeutic responses in the recurrent ovarian cancer disease setting. EP0057 is an investigational nanoparticle-drug conjugate administered intravenously. The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057, and therefore of the payload Camptothecin, to translate into maximum tumour cell killing.

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IGYO21019 / AVB500-OC-004 / GOG-3059 / Moore

Lead Researcher: Richard Moore

This is a randomized, double-blind Phase 3 study to compare the efficacy and safety of batiraxcept (AVB-S6-500) in combination with paclitaxel (PAC) versus placebo in combination with PAC in patients with platinum resistant recurrent ovarian cancer.

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IHAN21022 / VX15-2503-12 / KEYNOTE B84 / Baumgart

Lead Researcher: Megan Baumgart

The purpose of the study is to evaluate the safety and tolerability of pepinemab in combination with pembrolizumab as first-line treatment and determine a recommended Phase 2 dose (RP2D) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).

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ILEU17106 / ARO-021 / Jane Liesveld

Lead Researcher: Jane Liesveld

A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.

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ILEU19039 / PrECOG / Kristen O'Dwyer

Lead Researcher: Kristen O'Dwyer

Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 70 will be randomized to receive gilteritinib or midostaurin during induction and consolidation. Patients will also receive standard chemotherapy of daunorubicin and cytarabine during induction and high-dose cytarabine during consolidation. Gilteritinib, is an oral drug that works by stopping the leukemia cells from making the FLT3 protein. This may help stop the leukemia cells from growing faster and thus may help make chemotherapy more effective. Gilteritinib has been approved by the Food and Drug Administration (FDA) for patients who have relapsed or refractory AML with a FLT3 mutation but is not approved by the FDA for newly diagnosed FLT3 AML, and its use in this setting is considered investigational. Midostaurin is an oral drug that works by blocking several proteins on cancer cells, including FLT3 that can help leukemia cells grow. Blocking this pathway can cause death to the leukemic cells. Midostaurin is approved by the FDA for the treatment of FLT3 AML. The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving combination chemotherapy for FLT3 AML.

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ILEU20017/AUTO1-AL1/Kristen O'Dwyer

Lead Researcher: Kristen O'Dwyer

This is a Phase Ib/II study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (ALL).

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ILUN19174, Mulford, QUILT-2.023, NSCLC, N803

Lead Researcher: Deborah Mulford

This is a phase 3, open-label, 3-cohort, randomized study to compare the safety and efficacy of N-803 in combination with the current standard of care (experimental arms) versus standard of care alone (control arms), as first-line treatment for subjects with stage 3 or 4 advanced or metastatic NSCLC. Treatment will continue for up to 2 years, or until the patient experiences confirmed progressive disease or unacceptable toxicity, withdraws consent, or if the investigator feels that it is no longer in the patient's best interest to continue treatment. Patients will be followed for disease progression, post-therapies, and survival through 24 months after the first dose of study drug.

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ILYM15080 / ZUMA-2 / Patrick Reagan

Lead Researcher: Patrick Reagan

The primary objective of the study is to evaluate the efficacy of brexucabtagene autoleucel (KTE-X19) in participants with relapsed/refractory mantle cell lymphoma (MCL)

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ILYM18152 / VLS-101-0001 / Paul Barr

Lead Researcher: Paul Barr

The purpose of this study is to evaluate the safety, pharmacokinetics, immunogenicity, and efficacy of zilovertamab vedotin given intravenously (IV) across a range of dose levels in participants with previously treated hematological cancers including acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), Burkitt lymphoma (BL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), Richter transformation lymphoma (RTL), and T-cell non-Hodgkin lymphoma (NHL).

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ILYM19167, Reagan, mRNA-2752-P101, Lymphoma, mRNA-2752

Lead Researcher: Patrick Reagan

The clinical study will assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.

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IMGUP22011 // 20321 // Sahasrabudhe

Lead Researcher: Deepak Sahasrabudhe

The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.

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IMLT19000, Turner, RPL-001-16, Solid Tumor, RP1, Nivolumab

Lead Researcher: Rachael Turner

RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

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IMMY18128 / Seattle / Brea Lipe

Lead Researcher: Brea Lipe

This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple myeloma (MM) and what side effects (unwanted effects) may occur. The study will have several parts. In Parts A and B, participants get SEA-BCMA by itself. This part of the study will find out how much SEA-BCMA should be given for treatment and how often. It will also find out how safe the treatment is and how well it works. In Part C of the study, participants will get SEA-BCMA and dexamethasone. In Part D, participants will get SEA-BCMA, dexamethasone, and pomalidomide. Dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. These parts of the study will find out whether these drugs are safe when used together.

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IMMY19114 /CC-220-MM-001/ Brea Lipe

Lead Researcher: Brea Lipe

This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.

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IMMY20022/CAEL101-301/Frank Passero

Lead Researcher: Frank Passero

AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.

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IMMY20043/ HPN217 /Brea Lipe

Lead Researcher: Brea Lipe

An open-label, Phase 1 study of HPN217 to assess the safety, tolerability and PK in patients with relapsed/ refractory multiple myeloma

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IMMY20058 /CAEL101-302/ Frank Passero

Lead Researcher: Frank Passero

AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival and it is safe and well tolerated in patients with stage IIIa AL amyloidosis.

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IMMY20144/ 64407564MMY1001/ Brea Lipe

Lead Researcher: Brea Lipe

The purpose of this study is to evaluate the efficacy of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

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Improving Well-Being for Older Adult Family Dementia Caregivers

Lead Researcher: Kathi Heffner

The purpose of the study is to examine the effects of the Mindfulness-Based Stress Reduction (MBSR) program and the Living Well (LW) for Dementia Caregivers program, compared to any usual care, to see if the programs might be associated with better immune function, physical and emotional health, and well-being. This study is looking for individuals age 55 and up who are caring for someone (such as a spouse, parent, close friend) who has dementia. Participation includes attending a weekly small group meeting at Lifespan over eight weeks for one of two study programs (determined randomly). Both programs address ways of improving physical and emotional well-being in the context of dementia caregiving.

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KL2TR001999 Gilmore ReFOCUS

Lead Researcher: Nikesha Gilmore

The purpose of the study is to examine the feasibility and safety of twelve weeks oral supplementation of Epigallocatechin-3-gallate (EGCG) in older survivors of cancer

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Knee Osteoarthritis Pain Study

Lead Researcher: John Markman

This research study will evaluate a new investigational drug called CNTX-6970 as a possible treatment for chronic osteoarthritis (OA) of the knee. This study also will look at the safety and effects of CNTX-6970 on your pain (as it relates to your overall activity).

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Liver Transplantation From Living Donors For Treatment Of Colon Cancer that metastasized to the liver

Lead Researcher: Roberto Hernandez alejandro

The goal of this study is to create a data registry to capture clinical, pathologic, and molecular data/outcomes for patients with metastatic colorectal cancer who undergo live donor liver transplantation.

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Lymphoma & Leukemia: Collection of specimens and epidemiological and clinical outcomes data in patients with hematological malignancies

Lead Researcher: Walter Burack

This research is being done because we hope that a better understanding of hematologic malignancies will allow us to develop new and better treatments.

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Management of the PDA Trial

Lead Researcher: Carl D'angio

Patent ductus arteriosus (PDA) is an extra blood vessel found in babies before birth and just after birth. In most babies who have an otherwise normal heart, the PDA will shrink and close on its own in the first few days of life. If it stays open longer, it may cause extra blood to flow to the lungs. This study estimates the risks and benefits of active treatment versus expectant management of premature babies with patent ductus arteriosus.

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Measuring Surgical Recovery After Radical Cystectomy

The intent of this study is to establish a registry of post‐surgical outcomes in patients undergoing radical cystectomy. The goals of this initiative are to obtain a detailed baseline of multiple patient‐reported outcomes (PRO) and clinician‐reported outcomes (CRO) as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes.

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Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial

Apnea of prematurity (AOP) is a condition in which premature infants stop breathing for 15 to 20 seconds during sleep. The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization.

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Multiple Myeloma

Lead Researcher: Brea Lipe

The purpose of this study is to collect clinical data along with bone marrow aspirate samples to see if there is a way to determine which patients are more or less likely to experience disease progression. This study will involve identifying different markers on the surfaces of the plasma cells and will look at protein expression. We will then correlate those findings with data from your medical records over time. If you decide to take part in this study, you will be asked to allow additional bone marrow aspirate and blood samples to be collected for research at several time points. These additional samples will be collected during routine testing time points as required for your routine care. We will also collect information about your disease and treatment from your medical record.

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Multiple Myeloma: Integrating Touchscreen-based Geriatric Assessment and Frailty Screening for Adults with Multiple Myeloma to Drive Personalized Treatment Decisions

Lead Researcher: Supriya Mohile

If you enter the study, you will be asked to complete an electronic questionnaire on a sponsor- provided electronic tablet during an already scheduled clinical visit to your medical oncology doctor’s office. The questionnaire will take about 10 minutes to complete; study staff will remain available to assist you.

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Myotonic Dystrophy and Facioscapulohumeral Muscular Dystrophy Registry

Lead Researcher: Al-rabi Tawil

Myotonic dystrophy (DM) and facioscapulohumeral muscular dystrophy (FSHD) are inherited disorders characterized by progressive muscle weakness and loss of muscle tissue. The purpose of this registry is to connect people with DM or FSHD with researchers studying these diseases. The registry will offer individuals with DM and FSHD an opportunity to participate in research that focuses of their diseases. The registry will also help scientists to accomplish research on DM and FSHD and to distribute their findings to patients and care providers.

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Novel blood test to identify early subclinical Kidney transplant rejection

Lead Researcher: Mohammed Karim

This is a prospective, multi-center, observational study. Subjects will have TruGraf® and TRAC™ testing at study enrollment and thereafter every 3 months. In addition subjects will have TRAC™ testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period. Participants should be at least 18 years old, have received a primary or subsequent deceased-donor or living-donor kidney transplant and and it should be at least 90 since the transplant.

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NRG-GU008 / RGUP20037 / INNOVATE / Hong Zhang

Lead Researcher: Hong Zhang

This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach.

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NRG-GU009 / RGUP21002 / PREDICT-RT / Kevin Bylund

Lead Researcher: Kevin Bylund

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.

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NRG-HN001 / RHAN14057 / Nasopharyngeal Carcinoma - EBV DNA / Yuhchyau Chen

Lead Researcher: Yuhchyau Chen

There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

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NRG-HN005 / CHAN19131 / Oropharyngeal Radiation Therapy / Deepinder Singh

Lead Researcher: Deepinder Singh

This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.

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Osteopathic Manipulative Medicine to Reduce Developmental Delays

Lead Researcher: Angela Tyson

This randomized clinical trial seeks to determine if osteopathic manipulative medicine (OMM) increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of Infant Motor Performance (TIMP).

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Outcome Disparities in Adolescents with Acute Lymphoclastic Leukemia (ALL)

Lead Researcher: Kristen O'Dwyer

We will establish two prospective groups of patients with Acute Lymphoclastic Leukemia (ALL): "Cohort A" will be enrolled on the study at the time of diagnosis while "Cohort B" will be enrolled during maintenance chemotherapy.

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PBRN00002 / ANBL00B1 / Mullen

Lead Researcher: Craig Mullen

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

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PBRN18054 / ANBL1531 / Andolina

Lead Researcher: Jeffrey Andolina

This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.

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PBRT14096 / ANBL1232 / Andolina

Lead Researcher: Jeffrey Andolina

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.

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PBRT17119 / ACNS1422 / Korones

Lead Researcher: David Korones

This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.

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PCCB17098 / APEC1621SC / Mullen

Lead Researcher: Craig Mullen

This Pediatric MATCH screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.

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PCCO15102 / APEC14B1 / EveryChild Protocol / Mullen

Lead Researcher: Craig Mullen

This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

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PGUK06001 / AREN03B2 / Mullen

Lead Researcher: Craig Mullen

This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

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PGUK19093 / ANBL1821 / Andolina

Lead Researcher: Jeffrey Andolina

This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.

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Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

Lead Researcher: Inna Hughes

This is a Phase 1/2a, open-label, single-dose, PK study of VALTOCO with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.

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Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis

Lead Researcher: Andrew Goodman

The purpose of this study is to evaluate the safety and tolerability of ATA188 as a monotherapy in Parts 1 and 2, to determine the recommended Part 2 dose (RP2D) of ATA188 as monotherapy in Part 1, and to evaluate the effect of ATA188 treatment on clinical disability, as assessed by sustained Expanded Disability Status Scale (EDSS) improvement at 12 months in Part 2 in participants with progressive forms of multiple sclerosis (MS) (primary progressive multiple sclerosis [PPMS] and secondary progressive multiple sclerosis [SPMS]).

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Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

Primary Biliary Cholangitis (PBC) formerly known as primary biliary cirrhosis is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) helps prevent liver damage and improves liver function. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC patients.

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PHEM15022 / PIDTC-6901 / Jeffrey Andolina

Lead Researcher: Jeffrey Andolina

This study is a prospective evaluation of children with Severe Combined Immune Deficiency (SCID) who are treated under a variety of protocols used by participating institutions. In order to determine the patient, recipient and transplant-related variables that are most important in determining outcome, study investigators will uniformly collect pre-, post- and peri-transplant (or other treatment) information on all children enrolled into this study. Children will be divided into three strata: Stratum A: Typical SCID with virtual absence of autologous T cells and poor T cell function Stratum B: Atypical SCID (leaky SCID, Omenn syndrome and reticular dysgenesis with limited T cell diversity or number and reduced function), and Stratum C: ADA deficient SCID and XSCID patients receiving alternative therapy including PEG-ADA ERT or gene therapy. Each Group/Cohort Stratum will be analyzed separately.

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PHEM15023 / PIDTC-6903 / Jeffrey Andolina

Lead Researcher: Jeffrey Andolina

Chronic granulomatous disease (CGD) is an inherited immune system abnormality in which bone marrow transplantation (BMT) has been shown to be curative. However the risks of transplantation are high and not all patients with CGD may need to undergo this high risk procedure. This study will determine the long term medical condition and daily functioning of participants with CGD after a transplant and if possible, compare these results to participants who do not undergo a transplant.

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Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

Lead Researcher: Trenton Tollefson

This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be assigned to receive treatment with either STARTSTIM or a sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.

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PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry

The objective of this study is to evaluate the safety of long-term treatment with Kuvan.

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PLEU18029 / AALL1631 / Mullen

Lead Researcher: Craig Mullen

This randomized phase III trial studies how well imatinib mesylate works in combination with two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL when given with strong chemotherapy, but the combination has many side effects. This trial is testing whether a different chemotherapy regimen may work as well as the stronger one but have fewer side effects when given with imatinib. The trial is also testing how well the combination of chemotherapy and imatinib works in another group of patients with a type of ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL", and because it is similar to Ph+ ALL, is thought it will respond well to the combination of agents used to treat Ph+ ALL.

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PLEU19175 / AALL1732 / Mullen

Lead Researcher: Craig Mullen

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

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PLEU20095 / AAML1831 / Mullen

Lead Researcher: Craig Mullen

This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.

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PMLT12010 / ALTE05N1 / Mullen

Lead Researcher: Craig Mullen

This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.

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PMLT18041 / AGCT1531 / Andolina

Lead Researcher: Jeffrey Andolina

This phase III trial studies how well active surveillance, bleomycin, etoposide, carboplatin or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating germ cell tumors.

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PMLT21052 / APEC1621A / Mullen

Lead Researcher: Craig Mullen

This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other places in the body and have come back or do not respond to treatment. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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PMLT21055 / APEC1621D / Mullen

Lead Researcher: Craig Mullen

This phase II Pediatric MATCH trial studies how well samotolisib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with TSC or PI3K/MTOR mutations that have spread to other places in the body (metastatic) and have come back (recurrent) or do not respond to treatment (refractory). Samotolisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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PMLT21057 / APEC1621F / Mullen

Lead Researcher: Craig Mullen

This phase II Pediatric MATCH trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back (recurrent) or do not respond to treatment (refractory) and have spread to other places in the body (advanced). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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PMLT21061 / APEC1621K / Mullen

Lead Researcher: Craig Mullen

This phase II Pediatric MATCH trial studies how well ivosidenib works in treating patients with solid tumors that have spread to other places in the body (advanced), lymphoma, or histiocytic disorders that have IDH1 genetic alterations (mutations). Ivosidenib may block the growth of cancer cells that have specific genetic changes in an important signaling pathway called the IDH pathway.

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PMLT21062 / APEC1621M / Mullen

Lead Researcher: Craig Mullen

This phase II pediatric MATCH trial studies how well tipifarnib works in treating patients with solid tumors that have recurred or spread to other places in the body (advanced), lymphoma, or histiocytic disorders, that have a genetic alteration in the gene HRAS. Tipifarnib may block the growth of cancer cells that have specific genetic changes in a gene called HRAS and may reduce tumor size.

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Preemie Hypothermia for Neonatal Encephalopathy

Lead Researcher: Carl D'angio

Encephalopathy is a general term that means brain disease, damage, or malfunction. This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly assign them to either receive hypothermia or participate in a non-cooled control group.

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RAISE: A Study of Ganaxolone for Treatment of Status Epilepticus

Lead Researcher: Trenton Tollefson

Potential participants may be identified in the emergency department, ICU or other units in the hospital, and will be consented/assented and then screened for inclusion/exclusion criteria prior to being randomized to start IP treatment. Investigational product (ganaxalone) will be administered as a 3-minute bolus that will be started with a continuous IV infusion lasting for 36 hours and followed by a 12- hour taper. After the Investigational Product has been discontinued, the follow-up period assessments/procedures will be collected every 24 hours through 120 hours and at the time of hospital discharge followed by weekly visits/contacts at Week 1, 2, 3 and 4. Males or females aged 18 or older and admitted to the hospital in a state of status epilepticus are eligible. Patients with a history of status epilepticus may pre-consent to participate in the study.

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Registry of Full-genome Data Linked with Clinical Data to Evaluate New Gene Associations in Breast Cancer

Lead Researcher: Ajay Dhakal

The purpose of this registry is to create a large-scale, population-based database. This database will match health information to genome data to identify new gene associations in breast cancer. The study will look at Agendia Breast Cancer tests, including MammaPrint® and BluePrint™, which are tests that help doctors analyze and profile breast cancer tumors.

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RTOG 1216 / RHAN13055 / Surgery and Postoperative Radiation / Yuhchyau Chen

Lead Researcher: Yuhchyau Chen

This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.

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S1806 / RGUB19120 / Atezolizumab in Localized Muscle Invasive Bladder Cancer / Michael Cummings

Lead Researcher: Michael Cummings

This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.

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Selumetinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)

Lead Researcher: Angela Girvin

This phase II Pediatric MATCH trial studies how well selumetinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway activation mutations that have spread to other places in the body and have come back or do not respond to treatment. Selumetinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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SILDI-SAFE: Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia

Lead Researcher: Gloria Pryhuber

This is a multicenter study of sildenafil in premature infants in Neonatal Intensive Care Units (NICUs) with severe bronchopulmonary dysplasia (BPD). Infants must be receiving respiratory support at enrollment.

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Social-Life Enhancing Activities for Caregivers

Lead Researcher: Benzi Kluger

This study examines a behavioral intervention to improve social connection and reduce loneliness for caregivers of a loved one with Dementia with Lewy Bodies (DLB). The intervention is called Social LEAF. The objective is to examine psychological mechanisms whereby Social LEAF delivered in a group and via video call reduces loneliness and improves positive emotions for older caregivers of loved ones with DLB. This is an 18-month Stage 2 study examining Social LEAF, which is strengths-based and teaches positive coping skills focused on improving social relationships and is delivered remotely in a group format. These two adaptations to the original LEAF intervention are included to provide a more potent means of improving social connection. A pilot phase with 20 caregivers (Aim 1) will address these adaptations regarding feasibility, acceptability, and signal for reducing loneliness, with refinements as needed. A second phase (Aims 2 and 3) will involve a randomized trial comparing Social LEAF to control (30 caregivers in each arm) on loneliness (primary outcome), positive affect (mechanism), and social engagement (mechanism). Data will also be collected on acceptability and perceived benefits using mixed methods. Aim 1 is to refine the LEAF intervention to target social relationships and loneliness. Aim 2 is to examine feasibility and acceptability of Social LEAF for DLB caregivers. Aim 3 is to examine efficacy of Social LEAF in reducing loneliness, increasing positive affect, and increasing social engagement.

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Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.

The purpose of the study is to determine whether T900607-sodium is effective and safe in treating hepatocellular carcinoma, a type of liver cancer.

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The Early Treatment for Retinopathy of Prematurity Study (ETROP)

The goal of the Early Treatment for Retinopathy of Prematurity Study (ETROP) is to test the hypothesis that earlier treatment in carefully selected cases will result in an overall better visual outcome than treatment at the conventional CRYO-ROP threshold point in the disease.

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The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis

Lead Researcher: Andrew Goodman

Determine the difference in disability at 16 weeks in participants with anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis treated with "first-line" immunomodulatory therapies provided as standard-of-care, and either inebilizumab (investigational agent) or placebo. Inclusion Criteria 1. Diagnosis of NMDAR encephalitis 2. Age ≥ 18 years 3. Change in mental status

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The Home Med Study

Lead Researcher: Jinjiao Wang

Older adults often take too many medications, including medications that are risky or no longer necessary considering the changes in older adults' health status over time. The process of reducing or stopping these unnecessary or risky medications is called deprescribing. Deprescribing is particularly needed during the time period after hospital discharge, given the many changes in medications that occur during and right after hospital discharge. The goal of this study is to figure out a way to facilitate deprescribing to optimize and simplify older adults' medications using readily available resources in home health care. Eligibility: 1. 65 years of age and older; and 2. having been hospitalized and discharged home in the previous 24 months; and 3. having received home health care services in the previous 24 months; and 4. taking more than five medications at the time of screening

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The REPLACE Registry-for people who take Cholbam/Kolbam (Cholic Acid)

Lead Researcher: Nanda Kerkar

This is a study for people who take Cholbam/Kolbam also known as Cholic acid. You will be in this study for 10 years and we will collect information about your health.

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To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter

The purpose of this study is to determine the optimum effective dose of recombinant plasmid DNA [pVGI.1(VEGF2)] gene therapy administered using an experimental cardiac direct injection catheter (Stiletto™) system needed to benefit patients with severe Angina Pectoris.

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Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have hematologic cancer.

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Treatment of stroke with argatroban versus eptifibatide vs standard of care

Lead Researcher: Curtis Benesch

The primary efficacy objective of the MOST trial is to determine if argatroban (100µg/kg bolus followed by 3µg/kg per minute for 12 hours) or eptifibatide (135µg/kg bolus followed by 0.75µg/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS) as compared with placebo in acute ischemic stroke (AIS) patients treated with standard of care thrombolysis (0.9mg/kg IV rt-PA or 0.25mg/kg IV tenecteplase or TNK) within three hours of symptom onset. Patients may also receive endovascular thrombectomy (ET) per usual care. Time of onset is defined as the last time the patient was last known to be well.

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UBMT15029 / Cord Blood IIT / Omar Aljitawi

Lead Researcher: Omar Aljitawi

This study is a single-center, treatment protocol with 4 possible preparative regimens, designed to validate the process of umbilical cord blood stem cell transplantation at our institution.

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UBMT16009 / MSKCC15 / Michael Becker

Lead Researcher: Michael Becker

The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant.

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UBMT17044 / HBO-UBC / Omar Aljitawi

Lead Researcher: Omar Aljitawi

The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs).

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UBRT21040 / Early START / Sara Hardy

Lead Researcher: Sara Hardy

High grade gliomas (HGGs) are rapidly progressive brain tumors resulting in death for most patients between 6 months and 2 years after diagnosis. It is important for patients with HGG to discuss and document their wishes at the end of life. However, many of these patients experience early changes in cognition which impede their decision-making. For this reason, these patients should have early discussions with their providers. However, implementation of this remains challenging in clinical practice. In this study, we will create an Early STructured Advanced care Referrals by Telehealth (Early START) visit for patients soon after their initial oncology visit. A checklist and pre-visit guide were developed to help guide the visit for both the provider and patient. Providers will receive special training in running these visits. Caregivers and/or family members will be encouraged to participate. Visits will be done using video or telephone and recorded. For patients who do not have access to technology for these visits, it will be provided. After the visit, patients, caregivers and/or family who participated, and providers will fill out surveys to address feasibility of having these extra visits and improve the visits for future. Patients will be followed until death. Caregivers and/or family who participated will be asked about whether end of life was in line with the patient's wishes. We will also use the patient's medical record to assess other aspects of end of life. We will compare end of life outcomes with other similar patients treated at our center.

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UCCO20134 / SICG / Loh

Lead Researcher: Kah poh Loh

This is a pilot study to evaluate the usability and feasibility of a telehealth-delivered advance care planning intervention among 20 older patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), their caregivers, and oncologists.

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UCCS19102 / MAAT-G JIT (Breast) / Magnuson

Lead Researcher: Allison Magnuson

Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training (MAAT) is a promising treatment for CRCD that improves perceived cognition in younger cancer survivors, but needs to be adapted for older adults to address their unique needs. The proposed study will adapt MAAT for older adults using feedback from key stakeholders (older adults with cancer and their caregivers), and subsequently test the ability of MAAT to improve or maintain cognition for older adults with breast cancer receiving adjuvant chemotherapy.

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UCCS19158, Karen Mustian, YOCAS

Lead Researcher: Karen Mustian

This feasibility phase II randomized controlled trial examines the preliminary efficacy of our standardized four-week YOCAS©® (Yoga for Cancer Survivors) intervention that is delivered virtually on insomnia and sleep quality in cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. The vast majority of patients with cancer experience some form of sleep impairment post-treatment. Yoga is safe, feasible, and effective for improving insomnia and sleep quality in cancer survivors. However, most of the yoga intervention was delivered in person. With the challenges and the social distancing regulation regarding the COVID-19 pandemic, adapting to virtual behavioral intervention is critically important and needed. Whether the yoga intervention delivered virtually to survivors provides a similar benefit of improving insomnia and sleep quality is unknown.

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UCCS20090 / UR GOAL / Loh

Lead Researcher: Kah poh Loh

This is a pilot study to evaluate the usability and feasibility of a patient-centered communication tool (University of Rochester-Geriatric Oncology Assessment for acute myeloid Leukemia or UR-GOAL) among 15 older patients with AML, their caregivers, and oncologists.

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UCCS20127 / Magnuson / MAAT-G Phase II

Lead Researcher: Allison Magnuson

Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training (MAAT) is a promising treatment for CRCD that improves perceived cognition in younger cancer survivors, but needs to be adapted for older adults to address their unique needs. The proposed study will adapt MAAT for older adults using feedback from key stakeholders (older adults with cancer and their caregivers), and subsequently test the ability of MAAT to improve or maintain cognition for older adults with breast cancer receiving adjuvant chemotherapy.

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UCCS20154 / APATIT-G / Akwaa

Lead Researcher: Frank Akwaa

The purpose of this study is to determine if using avatrombopag in patients with thrombocytopenia due to temozolomide treatment can safely improve a patient's platelet count and allow the patient to complete the temozolomide treatment course as planned.

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UCCS21026 / eGAP / Loh

Lead Researcher: Kah poh Loh

This project assesses the feasibility and usability of the geriatric assessment platform (electronic Geriatric Assessment Platform or eGAP in 50 older patients with cancer, their caregivers, and their oncology team. Using an iterative process, we will refine the eGAP based on input from stakeholders.

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UCCS21043 / RCT mHealth Exercise Intervention / Loh

Lead Researcher: Kah poh Loh

This is a phase 2 randomized controlled trial (RCT) to assess the preliminary efficacy of the a mobile health exercise intervention (GO-EXCAP) versus a chemotherapy education control in 100 older patients with MN receiving outpatient chemotherapy on physical function and patient-reported outcomes (fatigue, mood, and quality of life). We will also explore the effect of the intervention on TNFα and related cytokine gene promoter methylation and their gene and protein expression.

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UGIP20027, Dunne, CA209-7WU, Pancreatic Ductal Adenocarcinoma, SX-682, Nivolumab

Lead Researcher: Richard Dunne

The main purpose of this research study is to determine the maximum tolerable dose (MTD) of SX-682 in combination with nivolumab in patients with metastatic pancreatic ductal adenocarcinoma who have completed at least 16 weeks of first line chemotherapy treatment without evidence of disease progression.

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UGUB20041, Fung, HCRN GU18-343, Urinary Bladder Neoplasms, Cabozantinib, Atezolizumab

Lead Researcher: Chunkit Fung

This is an open-label phase II study assessing the activity of cabozantinib combined with atezolizumab in patients with resectable muscle-invasive urothelial carcinoma who are ineligible for cisplatin-based therapy or decline cisplatin-based therapy. Each cycle equals 21 days. The dose of atezolizumab is 1200 mg IV flat dose every 3 weeks (Day 1) plus cabozantinib 40 mg orally daily (Day 1 through Day 21). Patients will receive three cycles of treatment prior to cystectomy unless they discontinue treatment for unacceptable toxicity or progressive disease by RECIST v1.1 or withdraw consent.

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UGUK17036 / Fung RCC Carevive Pilot IIT / Chunkit Fung

Lead Researcher: Chunkit Fung

To determine if Carevive software, which monitors treatment-related toxicities and then generates self-care management plans for these symptoms, will be feasible to implement among patients with metastatic renal cell carcinoma (RCC). Additionally for collection of preliminary data on treatment-related toxicities, quality of life, distress level, and drug adherence.

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UGUP18071 / DORA / Chunkit Fung

Lead Researcher: Chunkit Fung

The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself.

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ULAB03012 / LEO / Richard Burack

Lead Researcher: Walter Burack

The goal of this infrastructure grant is to establish and maintain a cohort of over 12,000 non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research that identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors, as well as the interaction among these factors, on short and long-term outcomes. These efforts will identify new approaches to improve the survival and well-being of NHL patients.

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ULEU07047 / RSRB20123 / Michael Becker

Lead Researcher: Michael Becker

This study is being performed to develop assays to determine the impact of the therapy patients receive for treatment of AML or MDS and to determine if these tests can identify those patients who are at a greater risk for having their disease relapse.

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ULEU18122 / Huselton WashU AML IST / Eric Huselton

Lead Researcher: Eric Huselton

The investigators will prospectively determine whether the relapse-free and overall survival in patients who have cleared their leukemia-associated mutations treated with standard consolidation chemotherapy is superior to what is expected based on historical controls. The investigators will also prospectively determine the relapse-free and overall survival of patients who have not cleared their mutations. Because the relapse rate of patients with persistent mutations is expected to be high, treatment with either standard of care consolidation therapy alone or alloSCT will be permitted, at the discretion of the treating physician.

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ULYM18040 / DLBCL / Carla Casulo

Lead Researcher: Carla Casulo

The overarching goals of this study are to measure levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.

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ULYM20030 / ML41690 Polatuzumab / Patrick Reagan

Lead Researcher: Patrick Reagan

The purpose of this study is to test the effectiveness and safety of polatuzumab vedotin in combination with R-miniCHP in patients 75 years and older with DLBCL.

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UMLT19186 / K08 JIT / Ramsdale

Lead Researcher: Erika Ramsdale

This is a single-site cluster-randomized trial to assess efficacy and implementation outcomes of deprescribing interventions in 72 older adults with polypharmacy (PP) and curable cancers initiating chemotherapy. Oncologists (as the cluster) will enroll 6 patients each and will be randomized to either a pharmacist-led deprescribing intervention or patient education intervention. Initial focus groups with oncologists, nurses, pharmacists, primary care physicians, and patients will provide data for initial adaptations to the pharmacist-led intervention arm, and 8 patients will be enrolled as a pre-trial cohort to further refine and adapt the pharmacist-led intervention.

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UMLT20123 / Van Veldhuizen / SMM & Prostate

Lead Researcher: Peter Van Veldhuizen

To explore the use of curcumin and piperine supplementation at a dose of 4 gram/5mg twice a day in early stage prostate cancer patient undergoing active surveillance or patients on observation for MGUS/ low-risk smoldering myeloma.

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UMMY18067 / RPCI Lipe Lenalidomide IIT / Brea Lipe

Lead Researcher: Brea Lipe

This phase I trial studies the safety of SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant together with sargramostim in treating patients with newly diagnosed multiple myeloma who are receiving lenalidomide maintenance therapy. Vaccines made from survivin peptide may help the body build an effective immune response to kill cancer cells that express survivin. Incomplete Freund's adjuvant may help stimulate the body's immune response to a vaccine treatment. Colony-stimulating factors, such as sargramostim, may increase the production of blood cells. Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant and sargramostim before or after the start of lenalidomide maintenance therapy may be a better treatment for multiple myeloma.

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UMMY20031/ UMCC 2018.056/ Brea Lipe

Lead Researcher: Brea Lipe

This phase 2 trial will test whether the combination of DaraRd (daratumumab + lenalidomide + dexamethasone) as induction therapy, followed by DRVd (daratumumab + lenalidomide + bortezomib + dexamethasone) consolidation therapy, if needed, will result in more patients achieving minimal residual disease (MRD)-negative status, relative to the standard of care. Consolidation therapy will be administered only to those patients with MRD-positive status after induction therapy. This is a study based on adaptive design for decision making of treatment options. Duration of therapy (daratumumab cycles) will depend on individual approach, response, evidence of disease progression and tolerance.

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UMMY20033 /Steroid Sparing Treatment/ Frank Passero

Lead Researcher: Frank Passero

The purpose of this study is to determine the effects of daratumumab and lenalidomide without steroids for treating patients with multiple myeloma.

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UOCPC22010/Loh

Lead Researcher: Kah poh Loh

The objective of this study is to conduct a pilot randomized trial to evaluate the preliminary efficacy of the UR-GOAL tool vs. usual care in improving shared decision making and communication between 100 older patients with AML and their oncologists.

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Upper GI Tract Cancer: 12 week home-based exercise study

Lead Researcher: Richard Dunne

We would also like to find out if this exercise intervention improves physical performance, day-to-day function, quality of life, and how the exercise may affect markers of inflammation in the blood over time. Cancer cachexia is a complex condition that can result in weight loss, muscle weakness, and/or tiredness, and may affect your normal daily activities and quality of life. Cachexia is common in patients with upper gastrointestinal tract cancers (esophageal, stomach, bile duct or liver cancer, and pancreatic cancer). There is little information on how these symptoms may develop or change as cachexia progresses, or how exercise may help improve these symptoms. Currently more information is needed on how physical performance and quality of life is affected by cachexia. There are no drugs approved for cachexia so understanding cachexia and its effect on the body may guide the development of interventions to help other patients with cancer cachexia.

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URCC 3705 / Genotoxicty Assessment / Yuhchyau Chen

Lead Researcher: Yuhchyau Chen

The purpose of the research study is to evaluate an automated, laser-based technique for measuring DNA damage caused by radiation during cancer treatment in immature red blood cells.

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Vaping/ Peter A. Wyman

Lead Researcher: Peter Wyman

Rates of adolescent vaping are increasing rapidly. Current high school student use of electronic vaping products (EVPs) rose from 1.5% in 2011 to 20.8% in 2018 - an increase from 220,000 to 3.05 million adolescent users. Effective, school-based interventions are urgently needed to protect adolescents from initiating or continuing use of electronic vaping products (EVPs). This study leverages a state-supported prevention initiative to test the effectiveness of a promising intervention that trains 8th-9th grade student peer leaders to deliver school-wide vaping prevention campaigns with ongoing adult mentoring. If study hypotheses are supported, the study will provide the first evidence of a school-based preventive intervention that reduces adolescent vaping behaviors, as well as insight into how peer communications can be harnessed to prevent vaping.

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