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临床试验/NCT02306837
NCT02306837Unknown2 期

A Phase II Trial of Consolidation Chemothetapy for Patients With Relapse or Refractory Lymphoid Malignancies After Autologous Stem Cell Transplantation

Shanghai Jiao Tong University School of Medicine2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
40
试验地点
2
主要终点
progression free survival

研究概览

简要总结

To imporve the outcome of patients with relapsed/refractory lymphoma, we conduct a clinical trial to test the efficacy and feasibility of consolidation chemotherapy after autologous stem cell transplantation

详细描述

Patients with relapsed or refractory lymphoma will be included. All patients will undergo PBSC mobilization with CTX and G-CSF. After sucessful collection of CD34+ over 1x109/L, autologous stem cel ltransplantation with Bu-Cy-E conditioning will be given. Two months after auto-HSCT, a PET-CT will be performed and all patients with CR, CRu and PR will recieved 3 cycles of mini-Bu-Cy-E as consolidation 3, 6 and 9 months after auto-HSCT. For patients with SD or PD after auto-HSCT will refered to the allogeneic transplantatio program and take off the study.

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

入选标准

  • Patients with relapsed or refracotry NHL or HD: PR or SD after first line salvage chemotherapy;
  • ECOG: 0-2
  • Tbil < 1.5x ULN and AST/ALT <2.5x ULN
  • With informed consent

排除标准

  • Life expectancy < 3 months
  • Women in pregnancy
  • uncontrollable infection disease
  • serum Cr >400mmol/l
  • uncontroled diabetis and heart disease

研究组 & 干预措施

Consolidation chemo

Experimental

Patients recieved 3 cycles of consolidation chemotherapy post-auto-HSCT: mini-Bu-Cy-E regimen

干预措施: Bu-CY-E (Drug)

结局指标

主要结局

progression free survival

时间窗: 2-year

次要结局

  • overall survival(2-year)
  • progression(2-year)
  • transplantation-related mortality(2-year)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiong HU

Head, Blood & Marrow Transplantation Center

Shanghai Jiao Tong University School of Medicine

研究点 (2)

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