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临床试验/NCT00774332
NCT00774332Unknown2 期

A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL

Cooperative Study Group A for Hematology2 个研究点 分布在 2 个国家目标入组 37 人开始时间: 2006年6月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
发起方
入组人数
37
试验地点
2
主要终点
Duration of complete remission, disease-free survival, overall survival, toxicities

研究概览

简要总结

A Phase II Study of CODOX-M/ IVAC in Relapsed/Refractory ALL

详细描述

The feasibility will be evaluated in terms of complete remission rate, duration of complete remission, disease-free survival, overall survival, and toxicities.

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
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with relapsed/resistant acute lymphoblastic leukemia
  • Patients must be between 15 and 65 years of age.
  • Estimated life expectancy of more than 3 months
  • ECOG performance status of 2 or lower, Karnofsky scale > 60 (see appendix I)
  • Adequate cardiac function (EF>45%) on echocardiogram or MUGA scan
  • Adequate kidney function (estimated Ccr >50 ml/min)

排除标准

  • Patients with CNS involvement of leukemic blasts will not be excluded.
  • Patients with extramedullary relapse(s) only will be excluded.

结局指标

主要结局

Duration of complete remission, disease-free survival, overall survival, toxicities

时间窗: 2009

次要结局

未报告次要终点

研究者

发起方
Cooperative Study Group A for Hematology
申办方类型
Network

研究点 (2)

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