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临床试验/NL-OMON55832
NL-OMON55832招募中2 期

Individualized dosing of fludarabine during innate allo SCT: A randomized phase II study (TARGET Study) - TARGET Study

niversitair Medisch Centrum Utrecht0 个研究点目标入组 98 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
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

入排标准

年龄范围
18 至 64(—)

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

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

研究者

发起方
niversitair Medisch Centrum Utrecht

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