drugset / Trial / NCT07007949
a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia
RandomizedSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2025-06-01
- Primary completion
- 2026-04-30
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Ivosidenib | Small molecule | 500 mg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |