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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)

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Trial Profile

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)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 15 Feb 2024

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At a glance

  • Drugs Azacitidine (Primary) ; Venetoclax (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions
  • Acronyms OMNIVERSE
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 09 Feb 2024 Status changed from active, no longer recruiting to completed.
    • 31 Oct 2023 Planned primary completion date changed from 24 Jun 2024 to 15 Aug 2024.
    • 15 Jun 2023 Results (n=5 of part 1) assessing the safety/tolerability and efficacy and determine the maximum tolerated dose of Oral-AZA + VEN in patients with AML presented at the 28th Congress of the European Haematology Association

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