EUCTR2005-005719-83-ES进行中（未招募）不适用
Prophylaxis of chronic graft-versus-host disease (cGvHD) with or without anti-Tlymphocyte-globulin (ATG Fresenius) prior allogeneic peripheral stem cell transplantation from HLA-identical siblings after myeloablative conditioning in patients with acute leukemia: a randomized phase III-study - ATGfamilystudy
niversitary Hospital Hamburg0 个研究点目标入组 160 人开始时间: 2012年3月15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
- 160
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
- •Acute myeloid leukemia in first or subsequent complete remission (de-novo or secondary AML).
- •Acute lymphoblastic leukemia in first or subsequent complete remission.
- •Patient's age: 18 ? 65 years.
- •Myeloablative standard conditioning.
- •HLA-identical sibling (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1).
- •No major organ dysfunctions.
- •Patient's 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 160
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •No complete remission at time of randomization.
- •Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as:
- •o Total bilirubin, SGPT or SGOT > 5 times upper the normal level.
- •o Left ventricular ejection fraction < 30 %.
- •o Creatinine clearance < 30 ml/min.
- •o DLCO < 35 % and/or receiving supplementary continuous oxygen.
- •Positive serology for HIV.
- •Pregnant or lactating women.
- •Serious psychiatric or psychological disorders.
- •Progressive invasive fungal infection at time of registration.
研究者
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