Ruxolitinib With Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor Plus Methotrexate and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis for HLA-haploidentical Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- 100-day cumulative II-IV aGVHD incidence after HSCT
研究概览
简要总结
Low Dose Ruxolitinib with Calcineurin Inhibitor and Methotrexate vs. Calcineurin Inhibitor plus Methotrexate and Mycophenolate mofetil as Graft Versus Host Disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.
详细描述
The is a prospective, randomized two-arm, and multicenter study. To compare the efficacy and safety of low-dose ruxolitinib combined with calcineurin inhibitor and methotrexate vs. calcineurin inhibitor plus methotrexate and mycophenolate mofetil as graft versus host disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be diagnosed with malignant hematological disease.
- •aged 12-70 years.
- •Received HLA-haploidentical hematopoietic stem cell transplantation.
- •received myeloablative conditioning
- •Karnofsky score ≥
- •creatinine clearance ≥60 mL/min (according to the Cockcroft-Gault formula). (7) liver and kidney function: aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of the normal range (ULN), total bilirubin ≤ 2 × ULN; serum creatinine ≤ 1.5 × ULN.
- •left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography (ECHO). 9) life expectancy >12 weeks. 10) Voluntarily signed the consent form and could understand and comply with the requirements of the study.
排除标准
- •Active autoimmune disease, such as SLE, rheumatoid arthritis, etc.
- •Current clinically significant active cardiovascular disease such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by New York Heart Association (NYHA) functional class, or a history of myocardial infarction within 6 months prior to enrollment.
- •Other serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes).
- •human immunodeficiency virus (HIV) infection.
- •cirrhosis of the liver, active hepatitis.
- •Pregnant or lactating women.
- •Patients who are concurrently enrolled in any clinical trials of similar drugs.
研究组 & 干预措施
RUX group
干预措施: Ruxolitinib+Calcineurin inhibitor+Methotrexate (Drug)
Control group
干预措施: Calcineurin Inhibitor+Methotrexate+Mycophenolate mofetil (Drug)
结局指标
主要结局
100-day cumulative II-IV aGVHD incidence after HSCT
时间窗: From the date of transplantation to the first occurrence of grade II-IV acute GVHD, assessed up to 100 days.
Cumulative incidence of grade II-IV acute GVHD occurring within the first 100 days following transplantation.
次要结局
- Cumulative Incidence of Chronic GVHD(From the date of transplantation to the first diagnosis of chronic GVHD, assessed up to 3 years.)
- Overall Survival(From the date of transplantation until death from any cause, assessed up to 3 years.)
- Adverse Events(From the date of transplantation to day 180 post-transplantation.)
- Cumulative Incidence of Relapse(From the date of transplantation to the first documented relapse, assessed up to 3 years.)
- GVHD-Free, Relapse-Free Survival(From the date of transplantation to the first occurrence of grade III-IV acute GVHD, systemic therapy-requiring chronic GVHD, relapse, or death, assessed up to 3 years.)
- Non-Relapse Mortality(From the date of transplantation to death without prior relapse or disease progression, assessed up to 3 years.)
- Relapse-Free Survival(From the date of transplantation to the first documented relapse or death from any cause, assessed up to 3 years.)
研究者
He Huang
Professor
Zhejiang University