Assessment of Reduction of Cord Blood Transplantation Toxicity by Using Reduced Intensity Conditioning in Patients With Acute Myeloid Leukemia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Transplant related mortality
研究概览
简要总结
Multicentric evaluation of the reduction of unrelated cord blood transplantation (UCBT) toxicity by using reduced intensity conditioning (RIC) in patients with acute myeloid leukaemia.UCBT related mortality and morbidity were limiting factors for the development of this procedure in adults. Non myeloablative conditioning regimen showed promising results and prospective evaluation has to be developed to confirm these retrospective data.
详细描述
Individual meta-analysis is planned to compare geno-identical transplantation with myeloid-ablative or non myeloid-ablative conditioning with UCBT after RIC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages : 4 to 65
- •De novo or secondary AML requiring allogeneic transplant
- •No donor (related or unrelated) compatible 10/10
- •Complete remission excepted CR1 with t(8;21) or inv (16) or t (15;17)
- •Smouldering AML without progression
- •Signed assent of recipient
排除标准
- •If CR1: AML with with t(8;21) or inv (16) or t (15;17)
- •Karnofsky < 50% - Clearance of creatinin < 40 ml/min
- •Transaminases > 8 N
- •Previous autologous or allogeneic transplantation within 6 month prior to the study (except if tandem)
- •total body irradiation contra-indicating 2 Gy TBI
- •local irradiation contra-indicating 2 Gy TBI
研究组 & 干预措施
1
Umbilical cord blood transplantation after reduced intensity conditioning
干预措施: Cord blood transplantation (Other)
结局指标
主要结局
Transplant related mortality
时间窗: At 2 years
次要结局
- Clinical efficiency (overall survival, event free survival, relapse incidence, acute and chronic GVHD incidence, graft failure, venoocclusive disease, interstitial pneumonia, infections, comorbidity score, quality of life and medico-economic impact)(at 2 years)