Prophylaxis of Chronic Graft-versus-host Disease (cGvHD) With or Without Anti-T-lymphocyte-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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic SCT from HLA-identical siblings with or without anti-T-lymphocyte-globulin at 2 years after transplantation
研究概览
简要总结
This multicenter, prospective phase III-study is to compare the administration of ATG FRESENIUS to the NON-administration of ATG FRESENIUS in a myeloablative conditioning regimen followed by allogeneic hematopoeitic stem cell transplantation from an HLA-identical sibling in patients with acute Leukemia. This clinical trial is to show that the administration of ATG FRESENIUS reduces the risk of chronic Graft-versus-Host disease after allogeneic stem cell transplantation from HLA-identical siblings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 consent
排除标准
- •No complete remission at time of randomization
- •Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
- •Total bilirubin, SGPT or SGOT 5 times upper the normal level
- •left ventricular ejection fraction <30%
- •Creatinine clearance <30 ml/min
- •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
研究组 & 干预措施
A
Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, RECEIVING ATG in conditioning regimen
干预措施: ATG FRESENIUS (Anti-Lymphocyte-Globulin) (Drug)
B
Hematopoeitic Stem Cell Transplantation from HLA-identical sibling, NOT RECEIVING ATG in conditioning regimen
干预措施: ATG FRESENIUS (Anti-Lymphocyte-Globulin) (Drug)
结局指标
主要结局
comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic SCT from HLA-identical siblings with or without anti-T-lymphocyte-globulin at 2 years after transplantation
时间窗: 2 years after transplantation
次要结局
- comparison of: acute GvHD/quality of life/treatment-related mortality/toxicity/ overall survival/progression-free survival/engraftment/chronic-GvHD-free survival(2 years after transplantation)
- incidence of infection/ AEs and ADRs(2 years after transplantation)