Status:
RECRUITING
Intermediate-dose HAD Regimen for CEBPA Double-mutated AML
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
AML
Eligibility:
All Genders
14-54 years
Phase:
NA
Brief Summary
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 transplant...
Detailed Description
This is a prospective, randomized, controlled clinical trial of patients diagnosed with CEBPA double-mutated AML. Patients who meet the inclusion criteria are randomly assigned to receive the intermed...
Eligibility Criteria
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).
- 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.
Key Trial Info
Start Date :
August 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06529250
Start Date
August 13 2024
End Date
September 1 2028
Last Update
January 16 2025
Active Locations (1)
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1
Blood Hospital
Tianjin, Tianjin Municipality, China, 300020