Status:
COMPLETED
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
Lead Sponsor:
Celgene
Collaborating Sponsors:
AbbVie
Conditions:
Leukemia, Myeloid, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04887857
Start Date
December 1 2021
End Date
January 8 2024
Last Update
February 12 2024
Active Locations (10)
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1
Local Institution - 104
Stanford, California, United States, 94305-5317
2
Local Institution - 110
Denver, Colorado, United States, 80218
3
Local Institution - 105
Boston, Massachusetts, United States, 02114
4
Local Institution - 106
New York, New York, United States, 10029