Intermediate-dose HAD Regimen for CEBPA Double-mutated AML

NCT06529250 · tracked via the Priya Life Science China tracker

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Phase

Not applicable

Started

2024-08-13

Last updated

2026-08-10

Condition(s) studied

AML

Investigational drug(s) / intervention(s)

HAD →Daunorubicin+CytarabineAll Daunorubicin trials (64) →All Cytarabine trials (114) →

HAD: 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.

Daunorubicin+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.

Study 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

Sex

ALL

Min age

14 Years

Max age

54 Years

Healthy volunteers

Inclusion Criteria: 1. AML diagnosed according to WHO-2022 classification with recurrent CEBPA mutations and containing mutation in the bZIP domain. 2. Older than 14 years old and younger than 55 years old 3. Male or female. 4. The Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of AML patients were 0-2 points. 5. Meet the following laboratory tests (performed within 7 days prior to treatment) 1) Total bilirubin ≤ 1.5 times of the upper limit of normal value (same age); 2) AST and ALT≤ 2.5 times of the upper limit of normal value (same age); 3) Blood creatinine \< 2 times of the upper limit of normal value (same age); 4) Myocardial enzymes \< 2 times of the upper limit of normal value (same age); 5) Echocardiography (ECHO) was performed to determine the ejection fraction of the heart within the normal range. Exclusion Criteria: 1. Patients who have previously received induction chemotherapy, regardless of efficacy. 2. Simultaneously suffering from malignant tumors of other organs and requiring treatment). 3. Pregnant or lactating women. Male or female patients participating in the trial must take contraceptive measures during the trial treatment period. 4. Active heart disease, defined as one or more of the following:1) Have a history of uncontrolled or symptomatic angina pectoris;2) Myocardial infarction less than 6 months prior to enrollment in the study;3) A history of arrhythmia requiring medication treatment or severe clinical symptoms;4) Uncontrolled or symptomatic congestive heart failure (\> NYHA grade 2);5) The ejection fraction is below the lower limit of the normal range. 5. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis). 6. Those who were not considered suitable for inclusion by the researchers.

Primary outcome measure(s)

Event-free survival (EFS) — up to 2 years after the date of the last enrolled participants
The interval from randomization to assessment of response after the second course of chemotherapy treatment if patients failed to achieve CR after two courses of induction therapy, the date of relapse, or the date of death, whichever occurred first.

Trial sites (1)

Facility	City	Region	Status
Blood Hospital	Tianjin	Tianjin Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06529250 on ClinicalTrials.gov ↗ ← All trials in China