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Venetoclax in Patients With MDS or AML in Relapse After AHSCT

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 13 to 11
    • Primary completion date: Sep 1, 2026 to Nov 15, 2026
    • Study completion date: Dec 1, 2027 to Sep 1, 2027
    v10
  2. Notable Primary completion date: Mar 1, 2026 to Sep 1, 2026
    • Study completion date: Sep 1, 2027 to Dec 1, 2027
    • Site details revised at 2 of 13 sites
    v9
  3. Notable Primary completion date: Sep 1, 2025 to Mar 1, 2026v8 Show 5 more changesShow less
    • Study sites: 14 to 13
    • Study completion date: Mar 1, 2026 to Sep 1, 2027
    • Secondary endpoints: details revised at 6 of 6 entries
    • Eligibility criteria shortened, about 4 words
    • Study description shortened, about 4 words
  4. Minor Site details revised at 2 of 14 sitesv7
  5. Minor Enrollment target: 48 to 55
    • Site details revised at 6 of 14 sites
    • Eligibility criteria shortened, about 5 words
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Site details revised at 1 of 14 sitesv5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2022 to Nov 23, 2022
    • Site details revised at 14 of 14 sites
    v4
  3. Notable Primary completion date: Mar 1, 2025 to Sep 1, 2025
    • Start date: Apr 1, 2022 to Sep 1, 2022
    • Study completion date: Sep 1, 2025 to Mar 1, 2026
    • Study description shortened, about 3 words
    v3
  4. Notable Start date: Feb 1, 2022 to Apr 1, 2022v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Study to assess venetoclax + azacitidine and donor lymphocyte infusion (DLI) in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) in relapse after allohematopoietic stem cell transplantation (AHSCT).
Trial Details
NCT Number NCT05226455
Lead Sponsor Groupe Francophone des Myelodysplasies
Collaborators: AbbVie
Conditions
(from sponsor)
MDS, AML
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov