Clinical Trial

Intermediate-dose HAD Regimen for CEBPA Double-mutated AML

Study acronym: HADCEBPA2023
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-08-30 -> 2027-08-30 2026-08-11
minor Completion pushed: 2028-09-01 -> 2029-09-01 2026-08-11
Trial Details
NCT Number NCT06529250
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions AML
Enrollment 148 participants
Start Date 2024-08-13
Primary Completion 2027-08-30 (estimated)
Study Completion 2029-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-10