EUCTR2018-000356-18-NL进行中（未招募）1 期
Individualized dosing of fludarabine during innate allo SCT: A randomized phase II study (TARGET Study) - TARGET Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 98
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
- •1.Adults (> 18 years)
- •2.AML, MDS, ALL, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD)
- •3.Indication for allo-SCT according to the policy of the local center
- •4.WHO performance status = 2
- •5.Written informed consent
- •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 98
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 98
排除标准
- •1.Relapse of disease within 5 months after previous allo-SCT
- •2.Bilirubin and/or transaminases > 2.5 x normal value*
- •3.Creatinine clearance < 40 ml/min*
- •4.Cardiac dysfunction as defined by:
- •-Unstable angina or unstable cardiac arrhythmias
- •-NYHA classification > II (Appendix B)
- •-Cardiac symptoms and/or history of cardiac disease AND a cardiac ejection fraction < 45%
- •5.Active, uncontrolled infection
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