JPRN-UMIN000004264已完成未知
A Pharmacokinetics (PK)/Phase I study of intravenous (i.v.) administration of mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis after allogeneic hematopoietic stem cell transplantation (allo-SCT) - A PK/Phase I study of i.v. MMF for GVHD prophylaxis
Kobe University Graduate School of Medicine0 个研究点目标入组 10 人开始时间: 2010年11月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
- 15years-old 至 69years-old(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Contraindication of MMF administration 2. SpO2 of less than 93% without oxygen inhalation 3. Serum creatinin of greater than 2.0mg/dl 4. Liver function with serum total bilirubin of greater than 2.0mg/dl, or AST of greater than 4.0 x ULN 5. Left ventricular ejection fraction of less than 50% 6. Past history of cardiac event, or significant cardiac disease 7. Uncontrolled diabetus mellitus 8. Another active neoplastic disease 9. Uncontrolled active infections 10. Serologically positive for HIV antibody and/or HBs antigen 11. Pregnant, or during breast feeding 12. Uncontrolled psychiatric disease 13. Allergic history to drugs used in the conditioning regimens or GVHD prophylaxis regimens 14. Patients suggested as ineligible by their attending physician
研究者
相似试验
进行中(未招募)
不适用
A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s LymphomaT-cell or B-cell precursor (BCP) acute lymphoblastic leukaemia (T-ALL or BCP-ALL) or T-cell Non Hodgkin’s lymphoma (T-NHL)MedDRA version: 9.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaMedDRA version: 9.1Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellEUCTR2008-002219-42-CZMundipharma Research Limited28
进行中(未招募)
不适用
A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s LymphomaEUCTR2008-002219-42-ATMundipharma Research Limited28
进行中(未招募)
不适用
A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s LymphomaT-cell or B-cell precursor (BCP) acute lymphoblastic leukaemia (T-ALL or BCP-ALL) or T-cell Non Hodgkin’s lymphoma (T-NHL)MedDRA version: 9.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaMedDRA version: 9.1Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellEUCTR2008-002219-42-NLMundipharma Research Limited28
进行中(未招募)
不适用
A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s LymphomaT-cell or B-cell precursor (BCP) acute lymphoblastic leukaemia (T-ALL or BCP-ALL) or T-cell Non Hodgkin’s lymphoma (T-NHL)MedDRA version: 9.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaMedDRA version: 9.1Level: HLGTClassification code 10025321Term: Lymphomas non-Hodgkin's T-cellEUCTR2008-002219-42-GBMundipharma Research Limited28
进行中(未招募)
1 期
A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s LymphomaEUCTR2008-002219-42-FRMundipharma Research Limited28
