Clinical Trial

VA vs DA for Newly Diagnosed Hig-risk AML

Recruiting Phase 2/3
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Record status
This record was last updated April 9, 2024 (before its estimated October 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-07-03.
Trial Details
NCT Number NCT05939180
Lead Sponsor The First Affiliated Hospital of Soochow University
Conditions Acute Myeloid Leukemia
Enrollment 116 participants
Start Date 2024-04-01
Primary Completion 2025-10-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2024-04-09