Intermediate-dose HAD Regimen for CEBPA Double-mutated AML

Not Applicable

Recruiting

• Conditions: AML

• Registration Number: NCT06529250
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. AML patients with recurrent genetic abnormalities CEBPAdm, who meet WHO-2016<br> classification;<br><br> 2. Older than 14 years old and younger than 55 years old<br><br> 3. Male or female.<br><br> 4. The Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of AML patients<br> were 0-2 points.<br><br> 5. Meet the following laboratory tests (performed within 7 days prior to treatment) 1)<br> Total bilirubin = 1.5 times of the upper limit of normal value (same age); 2) AST<br> and ALT= 2.5 times of the upper limit of normal value (same age); 3) Blood<br> creatinine < 2 times of the upper limit of normal value (same age); 4) Myocardial<br> enzymes < 2 times of the upper limit of normal value (same age); 5) Echocardiography<br> (ECHO) was performed to determine the ejection fraction of the heart within the<br> normal range.<br><br>Exclusion Criteria:<br><br> 1. Patients who have previously received induction chemotherapy, regardless of<br> efficacy.<br><br> 2. Simultaneously suffering from malignant tumors of other organs and requiring<br> treatment).<br><br> 3. Pregnant or lactating women. Male or female patients participating in the trial must<br> take contraceptive measures during the trial treatment period.<br><br> 4. Active heart disease, defined as one or more of the following:1) Have a history of<br> uncontrolled or symptomatic angina pectoris;2) Myocardial infarction less than 6<br> months prior to enrollment in the study;3) A history of arrhythmia requiring<br> medication treatment or severe clinical symptoms;4) Uncontrolled or symptomatic<br> congestive heart failure (> NYHA grade 2);5) The ejection fraction is below the<br> lower limit of the normal range.<br><br> 5. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).<br><br> 6. Those who were not considered suitable for inclusion by the researchers.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival (EFS)

Secondary Outcome Measures

Name	Time	Method
Complete response rate (CR);30-day mortality;overall survival;Event-free survival censored at hematopoietic stem cell transplantation;Relapse free survival censored at hematopoietic stem cell transplantation;overall survival censored at hematopoietic stem cell transplantation;60-day mortality;Relapse free survival(RFS)