Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allogeneic Hematopoietic Stem Cell Transplant Recipients With FLT3 Negative Acute Leukemia
试验速览
- 阶段
- 2 期
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- Incidence of leukemia relapse
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of sorafenib maintenance after allo-HSCT in FLT3-negative acute leukemia patients.
详细描述
Sorafenib is a multikinase inhibitor that blocks multiple pathways involved in the development and progression of acute leukemia, such as FLT3-ITD, the RAS and RAF gene families, KIT, and the VEGF and PDGF receptors. Recently, two back-to-back randomized controlled trials both reveal that sorafenib maintenance after allo-HSCT could prevent relapse in patients with FLT3-ITD AML, resulting in a survival benefit. Sorafenib has also been explored in the treatment of acute leukemia without FLT3 mutations and shown promising results. Currently, relapse remains the major cause of transplant failure, especially for high-risk and refractory acute leukemia patients. Once patients relapse after allo-HSCT, the prognosis is dismal. Therefore, prevention of relapse is of great importance to improve the prognosis. Based on the current research status, we plan to conduct a prospective, multicenter, phase 2 randomized controlled trial to explore the efficacy and safety of sorafenib maintenance after allo-HSCT in FLT3-negative acute leukemia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with FLT3-negative acute leukemia undergoing first allo-HSCT
- •Age 18 to 65 years old with ECOG performance status 0-2
- •Hematopoietic recovery within 60 days post-transplantation
- •Sign informed consent form, have the ability to comply with study and follow-up procedures
排除标准
- •Acute promyelocytic leukemia (AML subtype M3)
- •Acute leukemia with FLT3-ITD or FLT3-TKD mutations
- •Philadelphia-positive acute lymphoblastic leukemia
- •Chronic myelogenous leukemia with blast crisis
- •Intolerance to sorafenib pre-transplantation
- •Life expectancy less than 30 days post-transplantation
- •Active aGVHD or uncontrolled infections within 60 days post-transplantation
- •Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
- •Respiratory failure ( PaO2 ≤60mmHg)
- •Hepatic abnormalities (total bilirubin ≥3 mg/dL, aminotransferase >2 times the upper limit of normal)
- •Renal dysfunction (creatinine clearance rate < 30 mL/min)
- •ECOG performance status 3, 4 or 5
- •With any conditions not suitable for the trial (investigators' decision)
研究组 & 干预措施
Sorafenib group
Sorafenib will be administered at 45-60 days post-transplantation and taken for one year.
干预措施: Sorafenib (Drug)
结局指标
主要结局
Incidence of leukemia relapse
时间窗: 1 year
次要结局
- Adverse effects(1 year)
- Overall survival(1 year)
- Leukemia-free survival(1 year)
研究者
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University