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  • NCT04887857

Active, Not Recruiting

A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML) - CC-486-AML-004

Updated: 12 June, 2023   |   ClinicalTrials.gov

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

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Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: CC-486 in combination with Venetoclax
Drug: CC-486 Drug: Venetoclax

Key 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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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