NCT01385072Unknown1 期
Pilot Study of Hematopoietic Stem Cell Transplantation From Two Matched Sibling Donors in Treating Patients With Poor Prognosis Acute Leukemia and Advanced Lymphoproliferative Malignancies
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Acute graft versus host disease rate,severity and response to treatment
研究概览
简要总结
Patients with active acute leukemia have dismal prognoses even with allogeneic transplantation.Thus,new measures to enhance graft versus leukemia effect and reduce relapse rates are needed.
Relapse risk after double umbilical cord transplantations have been shown to be significantly lower compared to matched sibling and matched unrelated donor transplantations due to better graft versus leukemia effect.
The investigators hypothesize, that concomitant transplantation from 2 matched siblings may improve GVL effect and reduce relapse rate in patients with high risk acute leukemias and other high risk hematological malignancies.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Patients with refractory or relapsed acute leukemia unable to receive myeloablative conditioning.
- •Patients with refractory or relapsed acute leukemia able to receive myeloablative conditioning but with the following factors:
- •AML- 2 or more of the following: duration of CR1 < 6 months, poor cytogenetics, circulating blasts, karnofsky <
- •ALL- age > 40 or second and additional relapse, or 2 or more of the following: BM blasts > 25%, age 18-39,first refractory relapse, donor CMV positive.
- •Patients with 2 matched siblings and donor age > 18 years old.
- •Patients with advanced multiple myeloma with life expectancy of less than 6 months with standard therapy or transplantation.
- •Patients with advanced lymphoma with life expectancy of less than 6 months with standard therapy or transplantation.
排除标准
- •Patient age < 18 years.
- •Donor age < 18 years.
- •Patients in remission or not fulfilling above disease criteria -
结局指标
主要结局
Acute graft versus host disease rate,severity and response to treatment
时间窗: 100 days
次要结局
- relapse rate(12 months)
研究者
研究点 (1)
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