Kristen M. O'Dwyer, M.D.

Awards

2016 - Present
Young Investigator Award
Sponsor: Southwest Oncology Group (SWOG)

2010 - 2013
Wilmot Cancer Research Fellowship
Sponsor: University of Rochester School of Medicine and Dentistry
Location: Rochester, NY

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Clinical Trials

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

Lead Researcher: Kristen M O'Dwyer

This study will determine if the drug KTE-X19 is safe and effective in treating 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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PrECOG: Open-Label, Randomized trial of Daunorubicin/Cytarabine and High Dose Cytarabine + Gilteritinib vs Midostaurin for Induction and Consolidation. FLT3 mutated patients will be stratified based on TKD vs ITD. Patients who are FLT3 ITD will be further stratified by Signal Ratio (high vs. low of FLT3 Wild Type) and Nucleophosmin 1-Mutated (NPM1) [positive vs negative].

Lead Researcher: Kristen M O'Dwyer

Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 65 will be randomly assigned to receive gilteritinib or midostaurin. Patients will also receive standard chemotherapy of daunorubicin and cytarabine. 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 standard combination chemotherapy for FLT3 AML.

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Understanding Causes of Outcome Disparities in Adolescents and Young Adults (AYA) with Acute Lymphoclastic Leukemia (ALL)

Lead Researcher: Kristen M 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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A Randomized Phase II Study of Ruxolitinib (NSC-752295) in Combination with BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) Patients with Molecular Evidence of Disease

Lead Researcher: Kristen M O'Dwyer

This randomized phase II trial studies how well ruxolitinib phosphate and dasatinib or nilotinib work in treating patients with chronic myeloid leukemia. Ruxolitinib, dasatinib, and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

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A Phase Ib Dose Escalation and Expansion, Multicenter, Open-label, Safety, Pharmacokinetic and Pharmacodynamic Study of APTO-253 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia or High-Risk Myelodysplasia

Lead Researcher: Kristen M O'Dwyer

This study is being done to evaluate the safety and effectiveness of APTO-253 for the treatment of patients with the condition of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.

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CLEU-15006: S1318: A Phase II Study of Blinatumomab and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients ≥ 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Negative Acute Lymphoblastic Leukemia (ALL) and of Dasatinib, Prednisone and Blinatumomab for Patients ≥ 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL,CLEU-15006: S1318: A Phase II Study of Blinatumomab and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients ≥ 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Negative Acute Lymphoblastic Leukemia (ALL) and of Dasatinib, Prednisone and Blinatumomab for Patients ≥ 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL

Lead Researcher: Kristen M O'Dwyer

This study will have 2 groups: subjects who do not have the Philadelphia chromosome mutation (Ph-) and subjects who do have the mutation (Ph+). Treatments for the two groups will be different and are outlined below. In general, there are 3 main steps to all of the treatments. Induction/Re-Induction treatment is given first. It is a treatment given over a short period of time (usually only a few months) to get rid of as many of the leukemia cells as possible very quickly. Post-Remission treatment is given next. It is given to get rid of any leukemia cells that are left once your leukemia goes into remission and to make sure the leukemia cells don’t come back over a short period of time (usually only a few months). Maintenance treatment is given last. It is a lower dose treatment given over a long period of time (up to several years) to help keep the leukemia cells from coming back. Depending on which arm of the study you are on, Blinatumomab will be given as part of induction/re-induction or post-remission along with standard chemotherapy.

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Publications

Journal Articles

9/29/2016
Ho TC, LaMere M, Stevens BM, Ashton JM, Myers JR, O'Dwyer KM, Liesveld JL, Mendler JH, Guzman M, Morrissette JD, Zhao J, Wang ES, Wetzler M, Jordan CT, Becker MW. "Evolution of acute myelogenous leukemia stem cell properties after treatment and progression." Blood.. 2016 Sep 29; 128(13):1671-8. Epub 2016 Jul 15.

9/1/2016
Tyagi V, Alwaseem H, O'Dwyer KM, Ponder J, Li QY, Jordan CT, Fasan R. "Chemoenzymatic synthesis and antileukemic activity of novel C9- and C14-functionalized parthenolide analogs." Bioorganic & medicinal chemistry.. 2016 Sep 1; 24(17):3876-3886. Epub 2016 Jun 16.

2/20/2016
O'Dwyer KM, Advani AS. "When to Treat Adults Like Children: Optimizing Therapy for Lymphoblastic Lymphoma in Young Adults." Journal of clinical oncology : official journal of the American Society of Clinical Oncology.. 2016 Feb 20; 34(6):533-8. Epub 2015 Dec 23.

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