Matched Unrelated vs. Haploidentical Donor for Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia With Identical GVHD Prophylaxis - A Randomized Prospective European Trial.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 167
- 试验地点
- 24
- 主要终点
- Relapse incidence at two years between both arms
研究概览
简要总结
Primary objective of this open label, two-arm, multicenter, multinational, randomized trial is to compare anti-leukemic activity of allogeneic stem cell transplantation for patients with acute leukemia in complete remission between a 10/10 HLA matched unrelated donor and a haploidentical donor.
The hypothesis: Haploidentical stem cell transplantation with post cyclophosphamide induces a stronger anti-leukemic activity in comparison to 10/10 HLA matched unrelated donor and reduces the risk of relapse at 2 years after stem cell transplantation by 10%.
详细描述
Secondary objectives are to assess and compare the safety and efficacy of study treatments therapy in both study arms on non-relapse mortality (NRM), relapse-free survival (RFS), Overall survival (OS), QOL, toxicity, development of acute and chronic GvDH as well as engraftment and chimerism and impact of measurable residual disease.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment A
Allogeneic stem cell transplantation from 10/10 HLA matched unrelated donor
干预措施: Allogeneic Stem Cell Transplantation (Drug)
Treatment B
Allogeneic stem cell transplantation from haploidentical donor
干预措施: Allogeneic Stem Cell Transplantation (Drug)
结局指标
主要结局
Relapse incidence at two years between both arms
时间窗: 2 years
The primary efficacy endpoint will be analyzed using cumulative incidence estimation to assess the subdistribution hazard rates for both treatment groups at two years after accounting for competing risk events.
次要结局
- Comparison of non-relapsed mortality (NRM) at 1 and 2 years after allogeneic SCT in both arms(At 1 and 2 years after allogeneic SCT)
- Overall survival at two years between both arms(2 years)
- Comparison of GVHD/relapse-free survival as Composite endpoint in both arms(Starting at day +30 (+/- 3 d) to 24 months (+/- 1 mo) after allogenic stem cell transplantation (SCT))
- Comparison of chronic graft-versus-host disease (cGVHD) according to the NIH consensus criteria of Jagasia et al. at 1 and 2 years after allogeneic SCT between both arms(At 1 and 2 years after allogeneic SCT)
- Overall survival for all patients assigned to one of the two treatment arms as time to event endpoint(through study completion, an average of two yeras)
- Comparison of immune reconstitution between both arms(At day 30, 100, 6 months, 1 year and 2 years after allogenic SCT)
- Comparison of acute graft-versus-host disease (aGVHD) on day +100 and 1 year (max grade) after allogeneic SCT according to the Glucksberg scale revised by Przepiorka et al. between both arms(On day +100 and 1 year (max grade) after allogeneic SCT)
- Comparison of toxicity of both regimens scored according to the current version of the NCI CTCAE between both arms(through study completion, an average of two yeras)
- Comparison of full donor chimerism between both arms(At day 30, 100, 6 months, 1 year and 2 years after allogenic SCT)
- Evaluation of Sorror Risk Score on outcome after allogeneic SCT(At baseline)
- Comparison of QOL (FACT-BMT) before and after transplantation at + 100 days, 6 months, 1 year, 2 years between both arms(At day 100, 6 months, 1 year and 2 years after allogenic SCT)