Clinical Trials
A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggrmtssive B-cell NHL (017006)
Lead Researcher: Patrick M Reagan
This is a Phase 2, open-label, multicenter study to determine the efficacy and safety of lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or are refractory to, a single line of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) and are ineligible for hematopoietic stem cell transplant (based on age, performance status, and/or comorbidities). Subjects will receive treatment with lisocabtagene maraleucel and will be followed for 2 years for safety, pharmacokinetics and biomarkers, disease status, quality of life, and survival.
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A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients (EA4181)
Lead Researcher: Patrick M 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 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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Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas,
Lead Researcher: Patrick M Reagan
This phase II/III trial tests whether it is possible to decrease the chance of high-grade B-cell lymphomas returning or getting worse by adding a new drug, venetoclax to the usual combination of drugs used for treatment. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2. Drugs used in usual chemotherapy, such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide, 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 venetoclax together with usual chemotherapy may work better than usual chemotherapy alone in treating patients with high-grade B-cell lymphomas, and may increase the chance of cancer going into remission and not returning.
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A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia (ZUMA-8)
Lead Researcher: Patrick M Reagan
Participants will receive conditioning chemotherapy (fludarabine and cyclophosphamide), followed by the investigational treatment, KTE-X19. KTE-X19 is a CAR-T Cell Therapy (infusion).
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IBMT17130: A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)
Lead Researcher: Patrick M Reagan
If you decide to participate in this study, you will be randomized or assigned to one of two study groups based on your previous response to therapy and the International Prognostic Index score, a tool used to predict the likely course of your disease.
The Experimental Treatment Group will undergo collection of white blood cells by a process called leukapheresis in order to manufacture your T cells into axi-cel, three days of conditioning chemotherapy, and a single infusion of axi-cel. If your Study Doctor believes the current status of your disease is rapidly progressing, you may receive steroid therapy while axi-cel is being manufactured.
The Standard of Care (SOC) Treatment Group will receive standard of care therapies including two or three cycles of second-line platinum-based combination chemotherapy regimens with rituximab; R-ICE (Rituximab, Ifosfamide, Carboplatin, Etoposide), R-DHAP (Rituximab, Dexamethasone, High-dose Cytarabine, Platinum) R-ESHAP (Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin) or R-GDP (Rituximab, Gemcitabine, Dexamethasone, Platinum), as selected by your Study Doctor. If your cancer responds to the chemotherapy treatment, you will also receive high dose therapy and ASCT per your Study Doctor.
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ILYM17113: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination with Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients with Diffuse Large B-Cell Lymphoma.
Lead Researcher: Patrick M Reagan
If you decide to participate in this study you will be randomly assigned by a computer program to one of the following treatment groups: polatuzumab vedotin and R-CHP with placebo, or R-CHOP with placebo. Since the difference between the treatment groups is polatuzumab vedotin in one group and vincristine (O) in the other, both groups will receive a placebo, which is a substance that looks like either polatuzumab vedotin or vincristine but contains no active medication. Neither you nor your study doctor may choose the group that you will be in. You will have an equal chance of being placed in either group. Neither you nor your study doctor will know which treatment you receive.
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Phase II Pilot study of brentuximab vedotin and dose-attenuated chemoimmunotherapy (R-CHP) in elderly patients with diffuse large B cell lymphoma (IST-2014-100578)
Lead Researcher: Patrick M Reagan
This study incorporates brentuximab vedotin into dose-reduced chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone) as initial therapy for elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL). Vincristine, which is typically part of the standard chemotherapy regimen, will be omitted due to overlapping toxicities with brentuximab vedotin.
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Publications
Journal Articles
10/13/2020
Locke FL, Rossi JM, Neelapu SS, Jacobson CA, Miklos DB, Ghobadi A, Oluwole OO, Reagan PM, Lekakis LJ, Lin Y, Sherman M, Better M, Go WY, Wiezorek JS, Xue A, Bot A. "Tumor burden, inflammation, and product attributes determine outcomes of axicabtagene ciloleucel in large B-cell lymphoma." Blood advances.. 2020 Oct 13; 4(19):4898-4911.
5/13/2020
Nastoupil LJ, Jain MD, Feng L, Spiegel JY, Ghobadi A, Lin Y, Dahiya S, Lunning M, Lekakis L, Reagan P, Oluwole O, McGuirk J, Deol A, Sehgal AR, Goy A, Hill BT, Vu K, Andreadis C, Munoz J, Westin J, Chavez JC, Cashen A, Bennani NN, Rapoport AP, Vose JM, Miklos DB, Neelapu SS, Locke FL. "Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium." Journal of clinical oncology : official journal of the American Society of Clinical Oncology.. 2020 May 13; :JCO1902104. Epub 2020 May 13.
4/2/2020
Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, Timmerman JM, Holmes H, Jaglowski S, Flinn IW, McSweeney PA, Miklos DB, Pagel JM, Kersten MJ, Milpied N, Fung H, Topp MS, Houot R, Beitinjaneh A, Peng W, Zheng L, Rossi JM, Jain RK, Rao AV, Reagan PM. "KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma." The New England journal of medicine.. 2020 Apr 2; 382(14):1331-1342.
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