drugset / Trial / NCT07028073
A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to learn if avapritinib combined with standard induction therapy works to treat newly diagnosed adult acute myeloid leukemia (AML) patients with KIT mutations and t(8;21)(q22;q22.1); inv(16)(p13.1q22) or t(16;16)(p13.1;q22). It will also investigate the safety and tolerability of this combination therapy. The main questions it aims to answer are: To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of avapritinib combined with chemotherapy by Dose-limiting toxicity (DLT). Does this combination therapy improve the rates of minimal residual disease (MRD) negativity and long-term survival outcomes?
Timeline
- Start
- 2025-05-15
- Primary completion
- 2027-05-15
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avapritinib | Small molecule | — | Oral |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | — |
| Background | Cytarabine | Small molecule | 100 mg/m2 | — |
| Background | Idarubicin | Small molecule | 12 mg/m2 | — |
| Background | Venetoclax | Small molecule | 400 mg | — |