Actively Recruiting
Intermediate-dose HAD Regimen for CEBPA Double-mutated AML
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-01-16
148
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intermediate-dose HAD Regimen for CEBPA Double-mutated AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with AML according to WHO-2022 classification with recurrent CEBPA mutations including bZIP domain mutation
- Aged between 14 and 54 years old
- Male or female
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) between 0 and 2
- Laboratory tests within 7 days before treatment showing: total bilirubin 8% 1.5 times upper normal limit, AST and ALT 8% 2.5 times upper normal limit, blood creatinine less than 2 times upper normal limit, myocardial enzymes less than 2 times upper normal limit, and normal heart ejection fraction by echocardiography
You will not qualify if you...
- Previous induction chemotherapy for AML
- Having other active malignant tumors needing treatment
- Pregnant or breastfeeding women; patients must use contraception during the trial
- Active heart disease including uncontrolled angina, recent myocardial infarction (within 6 months), arrhythmia needing treatment, severe heart failure above NYHA grade 2, or low heart ejection fraction
- Serious infectious diseases such as untreated tuberculosis or pulmonary aspergillosis
- Any condition judged unsuitable for inclusion by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Blood Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
H
Hui Wei, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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