Clinical Trial

a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia

Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated June 6, 2025 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a single arm, open-label, multicenter clinical trial to evaluate the efficacy and safety of ivosidenib+venetoclax+ azacitidine in adult Chinese subjects with newly diagnosed IDH1m AML.A total of approximately 42 China Nationwide subjects with newly diagnosed IDH1m AML will participate in the study.The primary endpoint of the study is the complete remission(CR) + CR with partial hematologic recovery(CRh) rate, and the key secondary endpoints are CR rate,event-free survival (EFS),overall survival (OS),the objective response rate (ORR).
Trial Details
NCT Number NCT07007949
Lead Sponsor The First Affiliated Hospital of Soochow University
Conditions Acute Myeloid Leukemia, IDH1 Gene Mutation, Ivosidenib
Enrollment 42 participants
Start Date 2025-06-01
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-06-06