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NCT06529250Recruiting

Intermediate-dose HAD Regimen for CEBPA Double-mutated AML

A Multicenter, Randomized, Controlled Clinical Trial of Intermediate-dose HAD Regimen for CEBPA Double-mutated Acute Myeloid Leukemia

Source: ClinicalTrials.gov · Last updated 10 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
148 (estimated)
First submitted
17 Jul 2024
Start date
13 Aug 2024
Primary completion date
30 Aug 2027
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
NCT number
NCT06529250

What you commit to

  • Study type: Interventional
  • Planned participants: 148
  • From 13 Aug 2024 to the primary completion date, 30 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have previously received induction chemotherapy, regardless of efficacy.

Other illness

  • Simultaneously suffering from malignant tumors of other organs and requiring treatment).
  • Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).

Lab values

  • 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.

Other

  • Pregnant or lactating women. Male or female patients participating in the trial must take contraceptive measures during the trial treatment period.
  • Those who were not considered suitable for inclusion by the researchers.

Who the study is looking for

  • 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.

Age in the registry: 14 years to 54 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Blood Hospital
Coordinator of this site? Confirm its status
TianjinChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.