Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation in Comparison to Consolidation Therapy Based Venetoclax for Elderly Patients With Acute Myeloid Leukemia After First CR
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Relapse-free survival
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
VAA group
干预措施: Venetoclax (Drug)
HSCT group
干预措施: Allogeneic transplant (Drug)
结局指标
主要结局
Relapse-free survival
时间窗: 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.
次要结局
- Non-Relapsed Mortality(Up to 2 years)
- Overall Survival(Up to 2 years)
- 2-years Relapse Rate(Up to 2 years)
研究者
He Huang
Discipline Leader of Bone Marrow Transplant Center
Zhejiang University