Testing a chemotherapy regimen for a leukemia with CEBPA double mutations
Compares an intermediate-dose HAD chemotherapy regimen with standard treatment in acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Intermediate-dose HAD Regimen for CEBPA Double-mutated AML
Key facts
- Where
- Tianjin, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 14 to 54 with newly diagnosed AML that has two CEBPA gene changes (including one in the bZIP domain) and who have not had induction chemotherapy.
- Age
- Older than 14 years and younger than 55 years (14 to 54 years).
- Sex
- Men and women can join.
- Disease stage
- AML diagnosed by WHO-2022 classification with recurrent CEBPA mutations, including a mutation in the bZIP domain. Physical fitness score (ECOG-PS) of 0 to 2.
- Earlier treatment
- No earlier induction chemotherapy, whatever the result of it was.
- Biomarker or test result
- Recurrent CEBPA mutations with a mutation in the bZIP domain.
Main reasons for not taking part
- Earlier induction chemotherapy
- Another cancer of another organ that needs treatment
- Pregnant or breastfeeding women
- Active heart disease, such as heart attack in the last 6 months or heart pumping below normal range
- Serious infection, such as uncured tuberculosis or pulmonary aspergillosis
Read by machine on 11 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 54 years old?
Source: NCT06529250, who can take part
Where in China
- Blood HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06529250
- Record updated
- 10 August 2026
- Original description
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.Read full original descriptionShow less
A Multicenter, Randomized, Controlled Clinical Trial of Intermediate-dose HAD Regimen for CEBPA Double-mutated Acute Myeloid Leukemia
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.
Inclusion: 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.
Exclusion: Patients who have previously received induction chemotherapy, regardless of efficacy; Simultaneously suffering from malignant tumors of other organs and requiring treatment); Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis); 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; Pregnant or lactating women. Male or female patients participating in the trial must take contraceptive measures during the trial treatment period; Those who were not considered suitable for inclusion by the researchers.