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VA vs DA for Newly Diagnosed Hig-risk AML

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Primary completion date changed from estimate of Oct 1, 2025 to Jun 13, 2026
    • Study completion pushed from Oct 1, 2027 to May 13, 2028
    v3
  2. Start date: Jul 1, 2023 to Apr 1, 2024v2 Show 6 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 108 to 116
    • Primary completion date: Jul 1, 2025 to Oct 1, 2025
    • Study completion date: Jul 1, 2027 to Oct 1, 2027
    • Secondary endpoints: 5 to 6
    • Study title expanded, about 1 word
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.
Trial Details
NCT Number NCT05939180
Lead Sponsor The First Affiliated Hospital of Soochow University
Conditions
(from sponsor)		 Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov