A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
NCT ID: NCT04887857
Last Updated: 2024-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2021-12-01
2024-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CC-486 in combination with Venetoclax
CC-486
Specified dose on specified days
Venetoclax
Specified dose on specified days
Interventions
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CC-486
Specified dose on specified days
Venetoclax
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2020-004941-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-486-AML-004
Identifier Type: -
Identifier Source: org_study_id
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