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

NCT07651176

Phase 2/3 Enrolling by invitation 267 enrolled First Affiliated Hospital of Zhejiang University
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

EvaluationDrugModalityDoseRoute
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