NCT06529250 Intermediate-dose HAD Regimen for CEBPA Double-mutated AML
| NCT ID | NCT06529250 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | AML |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 148 participants in total. It began in 2024-08-13 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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 ≤ 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 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.
Contact & Investigator
Hui Wei, MD
PRINCIPAL INVESTIGATOR
Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Frequently Asked Questions
Who can join the NCT06529250 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 54 Years, studying AML. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06529250 currently recruiting?
Yes, NCT06529250 is actively recruiting participants. Contact the research team at weihui@ihcams.ac.cn for enrollment information.
Where is the NCT06529250 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06529250 clinical trial?
NCT06529250 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Hui Wei, MD at Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. The trial plans to enroll 148 participants.