RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NCT06571825
- Lead Sponsor
- He Huang
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 118
Inclusion Criteria:<br><br> - Diagnosed with AML according to the 2022 WHO diagnostic criteria;<br><br> - Age 60-75 years;<br><br> - Intermediate to high-risk AML according to the ELN criteria, AML with<br> myelodysplasia-related changes (AML-MRC) or therapy-related AML (t-AML), or<br> core-binding factor AML (CBF-AML) with D816 KIT mutation; or newly diagnosed<br> hypercellular leukemia (WBC = 10×10^9/L);<br><br> - Achieved CR or CR with incomplete hematologic recovery (CRi) after one to two<br> courses of induction chemotherapy;<br><br> - Have a matched related, haploidentical, or mismatched unrelated hematopoietic stem<br> cell donor;<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;<br> Creatinine clearance = 60 mL/min (calculated using the Cockcroft-Gault formula);<br><br> - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3× the upper<br> limit of normal (ULN), and total bilirubin = 2× ULN;<br><br> - Echocardiography (ECHO) showing left ventricular ejection fraction (LVEF) = 50%;<br> Expected survival > 8 weeks;<br><br> - Voluntarily signed the informed consent form and can understand and comply with the<br> study's requirements.<br><br>Exclusion Criteria:<br><br> - Currently has clinically active cardiovascular disease, such as uncontrolled<br> arrhythmias, uncontrolled hypertension, congestive heart failure, any class 3 or 4<br> heart disease according to the New York Heart Association (NYHA) functional<br> classification, or a history of myocardial infarction within 3 months before<br> screening;<br><br> - Other severe diseases that may limit the patient's participation in this trial<br> (e.g., severe infection, renal failure);<br><br> - Known human immunodeficiency virus (HIV) infection or severe viral hepatitis not<br> controlled by medication;<br><br> - Pregnant or breastfeeding women;<br><br> - Unable to understand, comply with the study protocol, or unable to sign the informed<br> consent form.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse-free survival
- Secondary Outcome Measures
Name Time Method Non-Relapsed Mortality;Overall Survival;2-years Relapse Rate