EUCTR2008-003540-11-NL进行中（未招募）1 期
Prevention of severe GVHD after allogeneic hematopoietic stem cell transplantation, applied as consolidation immunotherapy in patients with hematological malignancies. A prospective randomized phase III trial. - HOVON 96 GVHD
HOVON Foundation0 个研究点目标入组 500 人开始时间: 2009年11月16日最近更新:
适应症
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
- 500
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
- •- Age 18-70 inclusive
- •- AML, MDS, ALL, MM, CML, CLL, NHL, HL, or a myeloproliferative disease (MPD)
- •- Planned allogeneic stem cell transplantation
- •- Related or unrelated donor with a 8/8 genotypical HLA match (HLA A, B, C, DRB1)
- •- WHO performance status 0-2
- •- Written Informed Consent
- •- Negative pregnancy test (if applicable)
- •- Patients who are willing and capable to use adequate contraception during Myfortic treatment (all pre-menopausal women)
- •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 490
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Renal dysfunction (serum creatinine > 150 mmol/L or clearance < 50 ml/min)
- •- Patients with active, uncontrolled infection
- •- Cord Blood transplantation
- •- Patients receiving ATG pre-transplantation as part of the conditioning regimen
- •- Patients with progressive disease in case of MM, CLL, NHL, HL
- •- Patients with > 5% marrow blasts in case of AML, ALL, CML
- •- Patients with EMD in case of AML, ALL, CML
研究者
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