A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML) (OMNIVERSE)
Status and phase
Completed
Phase 1
Conditions
Leukemia, Myeloid, Acute
Treatments
Drug: CC-486
Drug: Venetoclax
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
6 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
N/A
Interventional model
Single Group Assignment
Masking
None (Open label)
6 participants in 1 patient group
CC-486 in combination with Venetoclax
Experimental group
Treatment:
Drug: Venetoclax
Drug: CC-486
Trial contacts and locations
10
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Data sourced from clinicaltrials.gov
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