RIC Allo-HSCT vs. Venetoclax-Based Consolidation in Elderly AML Patients After First CR
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Drug: Allogeneic transplant
- Registration Number
- NCT06571825
- Lead Sponsor
- He Huang
- 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 long-term survival rate remains very low, with a 5-year survival rate of only 5% to 10%. The introduction of the BCL-2 inhibitor venetoclax (Ven) has improved the induction remission rates in elderly patients. However, the question of whether to use chemotherapy maintenance or proceed with allogeneic hematopoietic stem cell transplantation (allo-HSCT) for post-remission consolidation therapy remains unclear due to the lack of prospective controlled studies. Therefore, our center plans to conduct a prospective, open-label, two-arm, non-randomized, single-center study to further explore the optimal consolidation treatment strategy for elderly AML patients at intermediate and high risk following induction complete remission (CR).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 118
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HSCT group Allogeneic transplant - VAA group Venetoclax -
- Primary Outcome Measures
Name Time Method Relapse-free survival Up to 2 years Relapse-free survival (RFS) is measured from the date of achievement of first remission until the date of hematologic relapse or death from any cause.
- Secondary Outcome Measures
Name Time Method Non-Relapsed Mortality Up to 2 years Non-relapsed mortality (NRM) is measured from the date of achievement of first remission until the date of death from any cause other than relapse.
Overall Survival Up to 2 years OS is measured from the date of reaching CR1 to the date of death from any cause.
2-years Relapse Rate Up to 2 years Relapse rate is defined as relapse probability at a given time point
Trial Locations
- Locations (1)
The First Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China