Fludarabine/Busulfan and Post-infusion Cyclophosphamide as Conditioning for Adult Patients With Lymphoid Malignancies Undergoing Allogeienc Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- acute graft versus host disease (GVHD)
研究概览
简要总结
Allogeneic stem cell transplantation is potential curative therapy for adult lymphoid malignancies. Based on our previous study, the condition with iv-busulfan (iv-BU) and cyclophosphamide (CTX) is feasible with low toxicity and transplantation mortality and long-term survival is comparable to most data reported with slightly higher relapse rate particularly for patients in CR2. In this study, the investigators aim to further improve the conditioning with Fludarabine + iv-BU and to use CTX after stem cell transfusion as consolidation for lymphoid malignancies and graft-versus-host disease (GVHD) prophylaxis.
详细描述
Patients with adult lymphoid malignancies received conditioning with Fludarabine + iv-BU. The GVHD was consisting of D+3 and D+4 CTX after stem cell transfusion. CSA will be added for all patients after D+5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •adult acute lymphocytic leukemia in 1st or second remission; lymphoid malignancies in 1st or second remission
- •age 16-60 years
- •with inform consent
- •no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
- •HLA matched related (6/6), unrelated donors (at least 8/10) or mismatched related donor (haplo)
排除标准
- •age less than 16 years or over 60 years
- •liver function/renal function damage (over 2 X upper normal range)
- •with mental disease
- •other contraindication of all-HSCT
研究组 & 干预措施
FLu-Bu-Cy
Patients received Fludarabine and iv Busulfan and post-infusion Cyclophosphamide as conditioning
干预措施: FLu-Bu-Cy (Drug)
结局指标
主要结局
acute graft versus host disease (GVHD)
时间窗: day 100
d100 incidence of acute GVHD, grade II-IV or grade III-IV
chronic GVHD
时间窗: 3 years
3-year incidence of chronic GVHD and extensive cGVHD
次要结局
- non-relapse mortality (NRM)(3 years)
- cumulated incidence of relapse (CIR)(3 years)
- event-free survival (EFS)(3 years)
- GVHD-free, relapse-free survival (GRFS)(3 years)
- overall survival (OS)(3 years)
研究者
Jiong HU
Head, Blood and Marrow Transplantation Center, Rui Jin Hospital
Shanghai Jiao Tong University School of Medicine