Clinical trial · Interventional
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
A Phase 1B, Open-label, Global, Multicenter, Dose Determination Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of CC-486 (ONUREG®) in Combination Therapy in Subjects With Acute Myeloid Leukemia (AML)
NCT04887857CI-TRIAL-00073918OMNIVERSEcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CC-486 | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CC-486 in combination with Venetoclax
- interventionNames
- Drug: CC-486
- Drug: Venetoclax
Primary outcomes (8)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- Up to 42 days after first dose
- measure
- Incidence of type of adverse events (AEs)
- timeFrame
- From informed consent form (ICF) signature to 28 days after last dose of study drug
- measure
- Incidence of frequency of AEs
- timeFrame
- From informed consent form (ICF) signature to 28 days after last dose of study drug
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.