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โ† Trials
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Intermediate-dose HAD Regimen for CEBPA Double-mutated AML

RecruitingNAAges 14 Years - 54 YearsAllInstitute of Hematology & Blood Diseases Hospitalโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 1.5 times of the upper limit of normal value (same age); 2) AST and ALTโ‰ค 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.
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What it tests

  • HAD
  • Daunorubicin+Cytarabine
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Where

1 site
Blood Hospital
Tianjin, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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