drugset / Trial / NCT07651176
Comparing the Efficacy of the LDA, LHAA, and DA Regimens in Young Adults With Low-Risk Acute Myeloid Leukemia Eligible for Intensive Chemotherapy
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase II/III, multicenter, randomized, three-arm, open-label, parallel controlled trial. The primary objective of this study is to compare the 2-years EFS rate of the LDA, LHAA, and DA regimens in newly diagnosed patients with low-risk acute myeloid leukemia who are eligible for intensive chemotherapy.
Timeline
- Start
- 2026-03-01
- Primary completion
- 2029-12
- Completion
- 2029-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | APG-2575 | Small molecule | 400 mg | Oral |
| Subject | APG-2575 | Small molecule | 600 mg | Oral |
| Subject | Aclarubicin | Small molecule | 12 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 100 mg/m2 | Subcutaneous |
| Subject | Cytarabine | Small molecule | 2 g | Subcutaneous |
| Subject | Daunorubicin | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Homoharringtonine | Small molecule | 2 mg/m2 | Intramuscular |
| Background | Azacitidine | Other / unclassified | 50 mg/m2 | — |