EUCTR2012-004008-37-IT进行中（未招募）1 期
A phase II multicentre open-label study on allogeneic stem cell transplantation from unrelated, cord-blood and family haploidentical donors in patients with active acute leukemia - Gandalf-01
GITMO0 个研究点目标入组 80 人开始时间: 2013年5月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Diagnosis of Primary induction Failure (PIF) or chemoresistant relapse in Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) patients
- •Activation of an alternative donor search by the Italian Bone Marrow Donor Registry (IBMDR)
- •Age >18<70
- •Unavailability of a HLA-matched related donor (MRD)
- •Performance status : ECOG<3
- •Written and signed informed consent
- •Life expectancy not severely limited by concomitant illness
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •Previous allogeneic transplant (autologous transplant is accepted)
- •Positive pregnancy test
- •Any active, uncontrolled infection.
研究者
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