A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)

ID#: NCT04887857

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: November 30, 2021

End Date: February 27, 2026

Contact Information:
BMS Study Connect Contact Center www.BMSStudyConnect.com
First line of the email MUST contain the NCT # and Site #.
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.

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