Status:
RECRUITING
RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR
Lead Sponsor:
He Huang
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60-75 years
Phase:
PHASE4
Brief Summary
Elderly patients with acute myeloid leukemia (AML) often face unfavorable prognostic factors such as multiple comorbidities, adverse cytogenetic profiles, and pre-existing hematological disorders. The...
Eligibility Criteria
Inclusion
- Diagnosed with AML according to the 2022 WHO diagnostic criteria;
- Age 60-75 years;
- Intermediate to high-risk AML according to the ELN criteria, AML with myelodysplasia-related changes (AML-MRC) or therapy-related AML (t-AML), or core-binding factor AML (CBF-AML) with D816 KIT mutation; or newly diagnosed hypercellular leukemia (WBC ≥ 10×10\^9/L);
- Achieved CR or CR with incomplete hematologic recovery (CRi) after one to two courses of induction chemotherapy;
- Have a matched related, haploidentical, or mismatched unrelated hematopoietic stem cell donor;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× the upper limit of normal (ULN), and total bilirubin ≤ 2× ULN;
- Echocardiography (ECHO) showing left ventricular ejection fraction (LVEF) ≥ 50%; Expected survival \> 8 weeks;
- Voluntarily signed the informed consent form and can understand and comply with the study's requirements.
Exclusion
- Currently has clinically active cardiovascular disease, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any class 3 or 4 heart disease according to the New York Heart Association (NYHA) functional classification, or a history of myocardial infarction within 3 months before screening;
- Other severe diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure);
- Known human immunodeficiency virus (HIV) infection or severe viral hepatitis not controlled by medication;
- Pregnant or breastfeeding women;
- Unable to understand, comply with the study protocol, or unable to sign the informed consent form.
Key Trial Info
Start Date :
July 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06571825
Start Date
July 17 2024
End Date
February 28 2028
Last Update
August 26 2024
Active Locations (1)
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1
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006