Extension of a Phase III Randomized Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen-HaploMUD-RIC-01
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Event-free survival
研究概览
简要总结
This study is an extension to younger patients of the currently ongoing national, multicenter, open-label, randomized phase III HAPLOMUDELDERLY which evaluates elderly patients with hematological malignancies, justifying an allo-HSCT from an alternative donor when a MRD has not been identified. It will extend the investigation of these two modalities of allo-HSCT to younger patients which are eligible to RIC.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hematological malignancy
- •Age<55 years
- •HCT-CI score ≥ 3 or non-eligible for myeloablative regimen
- •Patients without a matched related donor
- •Patients eligible for an allogeneic HSCT from an alternative donor
- •Able to comply with the protocol
- •Written informed consent
- •Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen
排除标准
- •Clinical or biological contraindication to allogeneic HSCT
- •Pregnant or breast-feeding women.
- •Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
- •Severe concomitant disease
研究组 & 干预措施
haploidentical related donors
干预措施: Hematopoietic stem cells transplantation (Procedure)
Matched unrelated donor
干预措施: Hematopoietic stem cells transplantation (Procedure)
结局指标
主要结局
Event-free survival
时间窗: 5 years
the time from randomization to the time of a first occurrence of an event with death, relapse or occurrence of severe cGVHD as event and considered as censored at the time of last follow-up visit
次要结局
未报告次要终点