Intermediate-dose HAD Regimen for CEBPA Double-mutated AML

Recruiting now · Not applicable

Conditions studied: AML

In brief

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.

Key facts

Study ID

NCT06529250

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

148

Starts

2024-08-13

Expected to finish

2029-09-01

Last updated by the study team

2026-08-10

Who can join

Age: 14 and older, up to 54. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• AML diagnosed according to WHO-2022 classification with recurrent CEBPA mutations and containing mutation in the bZIP domain.
• Older than 14 years old and younger than 55 years old
• Male or female.
• The Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of AML patients were 0-2 points.
• 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.

You may not qualify if…

• Patients who have previously received induction chemotherapy, regardless of efficacy.
• Simultaneously suffering from malignant tumors of other organs and requiring treatment).
• Pregnant or lactating women. Male or female patients participating in the trial must take contraceptive measures during the trial treatment period.
• 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.
• Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).
• Those who were not considered suitable for inclusion by the researchers.

Where it is running

• Blood Hospital — Tianjin, Tianjin Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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