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NCT04887857: OMNIVERSE
A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)
Completed
Phase 1
Last updated 12 February 2024
What this trial tests
Phase 1 trial testing CC-486 in Leukemia, Myeloid, Acute in 6 participants. Completed in 8 January 2024.
Timeline
1 December 2021
Primary endpoint
8 January 2024
8 January 2024
8 January 2024
Quick facts
| Lead sponsor | Celgene |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 1 December 2021 |
| Primary completion | 8 January 2024 |
| Estimated completion | 8 January 2024 |
| Sites | 10 locations across United States, Australia |
Drugs / interventions tested
- CC-486
- Venetoclax (venetoclax) — full drug profile →
Conditions studied
- Leukemia, Myeloid, Acute — all drugs for Leukemia, Myeloid, Acute →
Sponsor
Celgene — full company profile →
Who can join
18 and older, any sex, with Leukemia, Myeloid, Acute. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Acute Myeloid Leukemia: 2025 Update on Diagnosis, Risk-Stratification, and Management.
Shimony S, Stahl M, Stone RM. · · 2025 · cited 102× · PMID 39936576 · DOI 10.1002/ajh.27625 -
The clinical impact of the molecular landscape of acute myeloid leukemia.
Kayser S, Levis MJ. · · 2023 · cited 91× · PMID 36722402 · DOI 10.3324/haematol.2022.280801 -
Clinical activity, pharmacokinetics, and pharmacodynamics of oral hypomethylating agents for myelodysplastic syndromes/neoplasms and acute myeloid leukemia: A multidisciplinary review.
Haumschild R, Kennerly-Shah J, Barbarotta L, Zeidan AM. · · 2024 · cited 12× · PMID 38509812 · DOI 10.1177/10781552241238979 -
Comprehensive view on chemotherapy-free management of acute myeloid leukemia by using venetoclax in combination with targeted and/or immune therapies.
Kegyes D, Tat A, Vizitiu AS, Vazar-Tripon D, et al · · 2025 · cited 6× · PMID 40804253 · DOI 10.1038/s41420-025-02678-4 -
Novel Mechanisms for Post-Transplant Maintenance Therapy in Acute Myeloid Leukemia.
Manobianco SA, Rakiewicz T, Wilde L, Palmisiano ND. · · 2022 · cited 6× · PMID 35912243 · DOI 10.3389/fonc.2022.892289 -
P567: PHASE 1B OMNIVERSE TRIAL: SAFETY AND TOLERABILITY OF ORAL AZACITIDINE IN COMBINATION WITH VENETOCLAX FOR TREATMENT OF ACUTE MYELOID LEUKEMIA
Fleming S, Roboz G, T. Fathi A, Y. Zhang T, et al · · 2023 -
Abstract Book for the 27th Congress of the European Hematology Association
· 2022
Verify or expand the search:
- PubMed search for NCT04887857
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CC-486
Trials testing the same drug.
- NCT05413018 — An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myel · Phase 2 · active not recruiting
- NCT04722601 — A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma · Phase 1, PHASE2 · terminated
- NCT04778410 — Study of Magrolimab Combinations in Participants With Myeloid Malignancies · Phase 2 · terminated
- NCT04174196 — A Study of Lenalidomide and CC-486 With Radiation Therapy in Patients With Plasmacytoma · Phase 2 · active not recruiting
- NCT03493646 — Evaluating in Vivo AZA Incorporation in Mononuclear Cells Following Vidaza or CC486 · Phase 2 · completed
Other recruiting trials for Leukemia, Myeloid, Acute
Currently open trials in the same condition.
- NCT06852222 — A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leuke · Phase 3 · recruiting
- NCT06651229 — A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms · Phase 1 · recruiting
- NCT06618001 — A Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms · Phase 1 · recruiting
- NCT06643962 — Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearan · NA · recruiting
- NCT06382168 — DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia · Phase 1, PHASE2 · recruiting
Other Celgene trials
Trials by the same sponsor.
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- NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting
- NCT06782490 — A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spastici · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04887857 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Celgene
- Last refreshed: 12 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04887857.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing