- FREE CLINICAL TRIALS FOR ACUTE MYELOID LEUKEMIA TRIAL
- FREE CLINICAL TRIALS FOR ACUTE MYELOID LEUKEMIA FREE
Patients who received therapy for MDS before transforming to AML (e.g., with hypomethylating agents or lenalidomide) are eligible - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 - Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device, oral contraceptive or double barrier device) while on study and must continue to do so for 3 months after stopping study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial. Only induction chemotherapy administered for AML will be considered for considerations of eligibility regarding prior therapy. Patients with history of MDS who received therapy for MDS and progressed to AML are eligible at the time of diagnosis of AML. Inclusion Criteria: - Signed, informed consent must be obtained prior to any study specific procedures - For the phase I portion of the study patients should have failed any number of prior therapies, which should include at least the following: - Patients with MDS should have failed prior therapy with a hypomethylating agent and/or with lenalidomide - Patients with AML should have failed any prior induction therapy or have relapsed after prior therapy - Patients with MDS who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless of any prior therapy for AML - Patients with any of the eligible diagnoses who have received no prior therapy are eligible if not candidates to receive standard therapy or if they refuse standard chemotherapy - For the phase II portion of the study, only patients who are previously untreated for AML.
FREE CLINICAL TRIALS FOR ACUTE MYELOID LEUKEMIA FREE
Overall response defined as complete response (CR), CR with incomplete platelet recovery (CRp) or CR with insufficient hematological recovery (CRi), morphologic leukemia free state (MLF), partial response (PR), or hematologic improvement (HI) Maximum tolerated dose of cytarabine and azacitidine (Phase I) After completion of study treatment, participants will be followed up at 28 days and then every 3-5 months thereafter. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
ARM II: Participants receive tosedostat PO QD on days 1-28 and azacitidine intravenously (IV) over 10-40 minutes or SC for on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM I: Participants receive tosedostat orally (PO) once daily (QD) on days 1-28 and cytarabine subcutaneously (SC) twice daily (BID) on days 1-10. Participants are assigned to 1 of 2 arms. OUTLINE: This is a phase I, dose-escalation of cytarabine and azacitidine followed by a phase II study. To observe the anti-tumor effects of tosedostat in combination with cytarabine or 5-azacytidine, if any occur. To determine the safety profile of tosedostat (oral) in combination with cytarabine (subcutaneous ) or azacitidine (5-azacytidine) in patients age 60 years or older with relapsed/refractory acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS).
It is not yet known whether giving tosedostat and cytarabine or azacitidine may work better in treating participants with acute myeloid leukemia or high risk myelodysplastic syndrome. Drugs used in chemotherapy, such as 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. Tosedostat and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
FREE CLINICAL TRIALS FOR ACUTE MYELOID LEUKEMIA TRIAL
This phase I/II trial studies the side effects and best dose of cytarabine and azacitidine and how well they work when giving together with tosedostat in treating older participants with acute myeloid leukemia or high risk myelodysplastic syndrome. Phase I/II Study of Cytarabine or 5-Azacitidine Combined With Tosedostat to Evaluate the Safety and Tolerability in Older Patients With Acute Myeloid Leukemia (AML) or High Risk MDS Tosedostat and Cytarabine or Azacitidine in Treating Older Participants With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
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