RecruitingNot ApplicableNCT06529250

Intermediate-dose HAD Regimen for CEBPA Double-mutated AML

A Multicenter, Randomized, Controlled Clinical Trial of Intermediate-dose HAD Regimen for CEBPA Double-mutated Acute Myeloid Leukemia

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

148 participants

Start Date

Aug 13, 2024

Study Type

INTERVENTIONAL

Conditions

AML

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.

Eligibility

Min Age: 14 YearsMax Age: 54 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a chemotherapy regimen (called HAD) at an intermediate dose for patients with a specific type of acute myeloid leukemia (AML) — a blood cancer — that has particular gene mutations called CEBPA mutations with a bZIP domain change. These mutations can affect how well patients respond to treatment. **You may be eligible if...** - You are between 14 and 55 years old - You have been diagnosed with AML with CEBPA mutations (specifically in the bZIP domain), per current WHO classification - You are in adequate physical health to receive chemotherapy **You may NOT be eligible if...** - You do not have the specific CEBPA mutation type required - You are outside the age range (under 14 or over 55) - You have serious organ problems that prevent you from tolerating chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHAD

Induction therapy:Homoharringtonine: 2mg/㎡/d, days 1-7 Cytarabine: (Ara-c 100mg/㎡/d, day 1-4; 1g/㎡ /q12h, day 5-7), Daunorubicin: (DNR 40mg/㎡/d, day 1-3). Reinduction therapy: Idarubicin (IDA) 10mg/㎡ for d1-3 , Ara-c 100mg/㎡ d1-7 , Cyclophosphamide (CTX350mg/㎡ d2, d5) . Patients who did not achieve CR after reinduction therapy were removed from the group. After achieving CR, they received high-dose cytarabine (3g/m2 q12h, 3 days) regimen for consolidation for 3 courses. Hematopoietic stem cell transplantation is recommended for patients with persistent MRD positive after treatment.

DRUGDaunorubicin+Cytarabine

Cytarabine: (Ara-c 100mg/㎡/d, day 1-7), Daunorubicin: (DNR 60mg/㎡/d, day 1-3) or idarubicin (IDA 12mg/㎡/d, day 1-3). Treatment did not achieve CR, and reinduction of IAC regimen was given. Reinduction therapy: Idarubicin (IDA) 10mg/㎡ ,d1-3, Ara-c 100mg/㎡ d1-7 , Cyclophosphamide (CTX350mg/㎡ d2, d5). Patients who did not achieve CR after reinduction therapy were removed from the group. After achieving CR, they received high-dose cytarabine (3g/m2 q12h, 3 days) regimen for consolidation for 3 courses. Hematopoietic stem cell transplantation is recommended for patients with persistent MRD positive after treatment.