Post Transplantation Cyclophosphamide With or Without Low-dose ATG for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- grade II-IV acute GVHD
研究概览
简要总结
All patients received Flu-BU-VP16 as myeloablative conditioning followed by cyclophosphamide (D+3 and +4) and subsequent tacrolimus. For patients with unrelated or haplo-donor received low-dose ATG at Day +15.
详细描述
For patients with high-risk lymphoid malignancies, patients will undergo allo-HSCT from HLA matched sibling, unrelated (9~10/10) donor or hallo-identical donors. For all patients will receive myeloablative conditioning with 5-day fludarabine, 2-day VP-16 and 3-day busulifan. For prophylaxis graft versus host disease (GVHD), patients will receive cyclophosphamide 50mg/kg daily on D+3 and +4 with subsequent tacrolimus starting at D+5. For patients receiving HSCT from unrelated or haplo-donor, low-dose ATG 2.5mg/kg will be given on Day +15.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with lymphoid malignancies: CR1 or CR2 for acute lymphoblastic leukemia; T cell lymphoma (any CR/PR); B cell lymphoma (PR1 or CR2), hodgkin's disease (CR2 or beyond), Sezary syndrome
- •patients with HLA matched sibling, unrelated (HLA 9~10/10 matched) or haplo-identical donor
排除标准
- •patients with active infection
- •patients with abnormal liver function damage: ALT/AST above 2X normal range
- •patients with abnormal renal function damage Scr>160µmol/L;
- •patients with insufficient pulmonary function (FEV1，FVC，DLCO<50%）and heart failure or with EF <50%)
- •patients with mental instability
- •unwilling to give inform consent
研究组 & 干预措施
PT-CY-FK +/- ATG
GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.
干预措施: PT-CY-FK +/-ATG (Drug)
结局指标
主要结局
grade II-IV acute GVHD
时间窗: Day 100
cumulated incidence of grade II-IV aGVHD
次要结局
- grade III-IV acute GVHD(Day 100)
- relapse rate(1 year)
- overall survival(1 year)
- Non relapse mortality (NRM)(Day 100)
- chronic GVHD (cGVHD)(1 year)
- non relapse mortality(1 year)
- moderate to sever chronic GVHD(1 year)
- GVHD-free relapse free survival (GRFS)(1 year)
研究者
Jiong HU
Head, Blood & Marrow Transplantation Program, Chief physician
Shanghai Jiao Tong University School of Medicine