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Oral Azacitidine Combined With Venetoclax in Previously Untreated Higher-risk Myelodysplastic Syndromes

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv11
  2. Primary completion date changed from estimate of Dec 2025 to Dec 1, 2025v10
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Nov 2025 to Dec 2025
    • Site details revised at 25 of 25 sites
    v9
  4. Study sites: 24 to 25v8
  5. Site contacts updated at 23 of 24 sitesv7
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  1. Study sites: 23 to 24v6
  2. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Study sites: 19 to 23
    • Start date changed from estimate of Nov 2023 to Dec 6, 2023
    • Eligibility criteria shortened, about 29 words
    • Secondary endpoints: details revised at 2 of 15 entries
  3. Start date: Sep 2023 to Nov 2023
    • Primary completion date: Sep 2025 to Nov 2025
    • Study completion date: Sep 2028 to Nov 2028
    v4
  4. Start date: Apr 2023 to Sep 2023
    • Study sites: 10 to 19
    • Primary completion date: Apr 2025 to Sep 2025
    • Study completion date: Mar 2028 to Sep 2028
    v3
  5. Start date: Mar 2023 to Apr 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase I/II open-label, dose-finding, multi-center study will assess safety and primary efficacy of Onureg and Venetoclax combination, to define the optimal biological dose and optimal treatment duration of Onureg to be used along with Venetoclax for further studies in previously untreated patients with higher-risk myelodysplastic syndromes (HR-MDS) not eligible to transplant.
Trial Details
NCT Number NCT05782127
Lead Sponsor Groupe Francophone des Myelodysplasies
Collaborators: Bristol-Myers Squibb, AbbVie
Conditions
(from sponsor)		 Untreated Myelodysplastic Syndrome
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov