Intermediate-dose HAD Regimen for CEBPA Double-mutated AML
ConditionAML
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-54
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HAD
- Daunorubicin+Cytarabine
Treatment groups
148 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov