NCT04897139招募中2 期
Phase II Clinical Trial of Flu-Bu-Mel-E (Fludarabine, Busulfan, Melphalan and Etoposide) as Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
In this phase II clinical trial, we evaluate the efficacy and feasibility of conditioning regimen of fludarabine 150mg/m2, busulfan 9.6mg/kg, melphalan 100mg/m2 and etoposide 800mg/m2 in patients with lymphoid malignancies.
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
- •lymphoid malignancies
- •donor available: HLA matched sibling, unrelated donor or haplo-identical related donor.
- •patients with ECOG <3
排除标准
- •inform consent not provided
- •ECOG >=3
- •poor liver function (enzyme >2N or bilirubin >2N)
- •poor renal function (Scr >2N)
- •poor cardiac function (EF <45%)
研究组 & 干预措施
treatment arm
Experimental
treatment arm
干预措施: Flu-Bu-Mel-E (Drug)
结局指标
主要结局
disease-free survival
时间窗: 1 year after allo-HSCT
event defined as disease progression, relapse or death of any causes
次要结局
- Overall survival(1 year after allo-HSCT)
- Non relapse morality(1 year after allo-HSCT)
- GVHD-free or relapse-free survival(1 year after allo-HSCT)
- Relapse(1 year after allo-HSCT)
研究者
Jiong HU
Head, BMT program, Rui Jin Hospital
Shanghai Jiao Tong University School of Medicine
研究点 (1)
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