Therapy Protocol ALL SCT BFM International-open, Multicenter, Controlled, Prospective Study for Therapy and Therapy Optimisation in Patients With Acute Lymphoblastic Leukemia (ALL) and an Indication for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 552
- 试验地点
- 2
- 主要终点
- event-free and overall survival after allogeneic HSCT, occurrence of acute and chronic Graft-versus-Host-Disease (GvHD), occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT
研究概览
简要总结
To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). To evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients with ALL (except for patients with B-ALL) who fulfil the following criteria:
- •age at time of initial diagnosis or relapse diagnosis, respectively
- •indication for allogeneic HSCT
- •complete remission (CR) is achieved before SCT
- •written consent of the parents (legal guardian) and, if indicated, the minor patient via "Informed Consent Form"
- •no pregnancy
- •no secondary malignancy
- •no previous HSCT
- •HSCT is performed in a study participating centre.
排除标准
- •not signed inform consent of the parents (legal guardian)
- •pregnancy
- •secondary malignancy
- •previous HSCT
结局指标
主要结局
event-free and overall survival after allogeneic HSCT, occurrence of acute and chronic Graft-versus-Host-Disease (GvHD), occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT
时间窗: 11 years
次要结局
未报告次要终点
