Intermediate-dose HAD for CEBPA Double-mutated AML
Intermediate-dose HAD Regimen for CEBPA Double-mutated AML
Recruiting
N/AInterventional Study
AML
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
14 – 54
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
148 (estimated)
Sponsor
Institute of Hematology & Blood Diseases Hospital, China · Other
Who this trial is looking for
This trial is looking for people aged 14 to 55 who have a specific type of leukemia called CEBPA double-mutated AML. If you join, you will receive a new treatment to see if it works better than current options.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with CEBPA double-mutated AML.
I am between 14 and 55 years old.
I am either male or female.
My performance status is between 0-2.
My lab tests show normal levels for bilirubin, AST, ALT, creatinine, and myocardial enzymes.
I have had an echocardiogram that shows my heart's ejection fraction is normal.
You may not be able to join if
I have received induction chemotherapy before.
I have other cancers that need treatment.
I am pregnant or breastfeeding.
I have active heart disease.
I have serious infectious diseases.
I am not considered suitable by the researchers.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 reg…
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.
Trial Locations
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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 …
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.
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