EUCTR2005-000279-16-FI进行中（未招募）不适用
Phase III Clinical Study of Allogeneic Stem Cell Transplantation with Reduced Conditioning(RICT) versus Best Standard of Care in Acute Myeloid Leukemia (AML) in First Complete Remission - RICTin AM
Sahlgrenska University Hospital0 个研究点目标入组 300 人开始时间: 2007年4月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •AML of intermediate or poor prognosis, in first complete remission following one or more courses of induction therapy - Age 50-70 years - Judged to be able to tolerate a RICT if a suitable donor is found -Judged to be able to tolerate conventional chemotherapy - Willing to undergo a RICT if a suitable donor is found - Signed informed consent prior to inclusion - Willing and able to comply with protocol requirements - At least one sibling without evident contraindications to the donation procedures and who is willing to have a blood sample drawn for HLA-typing.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •AML with good risk features - Additional malignancy which might interfere with the primary endpoint of the study - serum creatinine >2 x the ULN - Abnormal liver function: ALT or AST > 3 x ULN - Planned to receive a full-dose conditioning or an URD transplant - Severe concurrent illness, such as congestive heart failure, severe arrhythmias, uncontrolled hypertension, diabetes, severe neurologic or psychiatric disorder, known HIV-positivity - Ongoing or suspected significant infection - Results of sibling's HLA-typing available
研究者
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