OMNIVERSE: A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
Study Details
Study Description
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) and newly diagnosed AML.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: CC-486 in combination with Venetoclax
|
Drug: CC-486
Specified dose on specified days
Other Names:
Drug: Venetoclax
Specified dose on specified days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Tolerated Dose (MTD) [Up to 42 days after first dose]
- Incidence of type of adverse events (AEs) [From informed consent form (ICF) signature to 28 days after last dose of study drug]
- Incidence of frequency of AEs [From informed consent form (ICF) signature to 28 days after last dose of study drug]
- Incidence of severity of AEs [From informed consent form (ICF) signature to 28 days after last dose of study drug]
- Incidence of relationship of AEs to study treatment [From informed consent form (ICF) signature to 28 days after last dose of study drug]
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests [From informed consent form (ICF) signature to 28 days after last dose of study drug]
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [From informed consent form (ICF) signature to 28 days after last dose of study drug]
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [From informed consent form (ICF) signature to 28 days after last dose of study drug]
Secondary Outcome Measures
- Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh) [Up to approximately 12 months]
- Overall Response Rate (ORR) [Up to approximately 12 months]
- Minimal Residual Disease (MRD) Response Rate [Up to approximately 12 months]
- MRD Conversion Rate [Up to approximately 12 months]
- Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi) [Up to approximately 12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Confirmation of the following for Acute Myeloid Leukemia (AML)
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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
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Agree to serial bone marrow aspirate/biopsies
Exclusion Criteria:
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Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype
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Received prior hypomethylating agent (HMA) therapy for myelodysplastic syndromes/Chronic myelomonocytic leukemia then develop AML within 4 months of discontinuing the HMA therapy
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Stanford University | Stanford | California | United States | 94305-5317 |
2 | Colorado Blood Cancer Institute | Denver | Colorado | United States | 80218 |
3 | Massachusetts General Hospital / Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02114 |
4 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
5 | Cornell University Weill Medical College | New York | New York | United States | 10065 |
6 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
7 | University of Oklahoma Peggy and Charles Stephenson Cancer Center | Oklahoma City | Oklahoma | United States | 73104 |
8 | MD Anderson Cancer Center | Houston | Texas | United States | 77003 |
9 | Alfred Hospital | Melbourne | Australia | 3004 |
Sponsors and Collaborators
- Celgene
- AbbVie
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CC-486-AML-004
- 2020-004941-35