Acute Myeloid Leukemia Clinical Trial

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

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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.

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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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

6

Study ID:

NCT04887857

Recruitment Status:

Completed

Sponsor:

Celgene

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There are 10 Locations for this study

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Local Institution - 104
Stanford California, 94305, United States
Local Institution - 110
Denver Colorado, 80218, United States
Local Institution - 105
Boston Massachusetts, 02114, United States
Local Institution - 106
New York New York, 10029, United States
Local Institution - 113
New York New York, 10065, United States
Local Institution - 102
Cleveland Ohio, 44195, United States
Local Institution - 111
Oklahoma City Oklahoma, 73104, United States
Local Institution - 101
Houston Texas, 77003, United States
Local Institution - 202
North Melbourne Victoria, 3002, Australia
Local Institution - 201
Melbourne , 3004, Australia
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Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

6

Study ID:

NCT04887857

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

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