Acute Myeloid Leukemia Clinical Trial
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
Summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.
Eligibility Criteria
Inclusion Criteria:
Confirmation of the following for Acute Myeloid Leukemia (AML)
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. ECOG 3 is allowed if participants are 18 to 74 years old with comorbidities
Agree to serial bone marrow aspirate/biopsies
Exclusion Criteria:
Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype
Received prior hypomethylating agent (HMA) therapy for myelodysplastic syndromes/Chronic myelomonocytic leukemia then develop AML within 4 months of discontinuing the HMA therapy
Prior history of malignancy unless the participant has been free of the disease for ≥ 1 year prior to the start of study treatment
Other protocol-defined inclusion/exclusion criteria apply
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There are 10 Locations for this study
Stanford California, 94305, United States
Denver Colorado, 80218, United States
Boston Massachusetts, 02114, United States
New York New York, 10029, United States
New York New York, 10065, United States
Cleveland Ohio, 44195, United States
Oklahoma City Oklahoma, 73104, United States
Houston Texas, 77003, United States
North Melbourne Victoria, 3002, Australia
Melbourne , 3004, Australia
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