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Brief Title: A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
Official Title: A Phase 1B, Open-label, Global, Multicenter, Dose Determination Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of CC-486 (ONUREG®) in Combination Therapy in Subjects With Acute Myeloid Leukemia (AML)
Study ID: NCT04887857
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Local Institution - 104, Stanford, California, United States
Local Institution - 110, Denver, Colorado, United States
Local Institution - 105, Boston, Massachusetts, United States
Local Institution - 106, New York, New York, United States
Local Institution - 113, New York, New York, United States
Local Institution - 102, Cleveland, Ohio, United States
Local Institution - 111, Oklahoma City, Oklahoma, United States
Local Institution - 101, Houston, Texas, United States
Local Institution - 202, North Melbourne, Victoria, Australia
Local Institution - 201, Melbourne, , Australia
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR