drugset / Trial / NCT06529250

Intermediate-dose HAD Regimen for CEBPA Double-mutated AML

NCT06529250

RandomizedParallel-groupOpen-labelTreatment

Summary

AML is highly heterogeneous in pathogenesis, and CEBPA double-mutated (CEBPAdm) AML is a common type of leukemia in China. Currently, no targeted therapies for CEBPAdm, and chemotherapy and transplantation are still the treatment options for CEBPA double-mutated AML. At present, the "3+7" treatment induction regimen of cytarabine combined with anthracyclines is still the first-line recommended regimen. In our retrospective study, the intermediate dose HAD regimen produced a 3-year RFS of 84.7% and a 3-year OS of 92.8% in CEBPAdm AML. Therefore, this project intends to confirm the efficacy of intermediate-dose HAD in the treatment of CEBPA double-mutated AML is superior to the conventional treatment regimen through the multi-center RCT study.

Timeline

Start
2024-08-13
Primary completion
2026-08-30
Completion
2028-09-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cytarabine Small molecule 100 mg/m2
Comparator Cytarabine Small molecule 1 g
Comparator Cytarabine Small molecule 3 g
Comparator Daunorubicin Small molecule 40 mg/m2
Comparator Daunorubicin Small molecule 60 mg/m2
Subject Homoharringtonine Small molecule 2 mg/m2
Comparator Idarubicin Small molecule 10 mg/m2
Comparator Idarubicin Small molecule 12 mg/m2
Background Cyclophosphamide Other / unclassified 350 mg/m2