Nonmyeloablative Allogeneic Stem Cell Transplantation in Elderly Patients With Hematological Malignancies:Results From the GITMO (Gruppo Italiano Trapianto Midollo Osseo)Multicenter Prospective Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
The study aimed to evaluate the efficacy of a nonmyeloablative conditioning consisting of fludarabine and total body irradiation in patients older than 60 years of age
详细描述
A total of 35 patients with hematological malignancies were treated with fludarabine (30 mg/m2 x 3-5 days) and 200 cCy TBI followed by allogeneic hematopoietic stem cell transplantation (HSCT) from a matched-sibling donor.
Neutrophil recovery occurred in 89% of the patients at a median time of 15 days. On day +30, 10 patients had > 95% donor chimerism, and 21 patients had mixed chimerism. The cumulative probabilities of grade II-IV acute GVHD and chronic GVHD were 51% and 84% respectively. Transplant-related mortality at 100 days and 1 year was 5% and 9% respectively. The probabilities of 1-year overall (OS) and progression-free survival (PFS) were 55% and 47% respectively. The estimated 1-year probability of OS and PFS for patients in early disease stages were 87% and 74% respectively , which were significantly higher than the survival and PFS estimates of 12% obtained in patients with advanced disease stages at the time of transplant
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with myeloid or lymphoid malignancy who were > 60 years old potentially treatable with stem cell transplant
排除标准
- •lack of an HLA-identical sibling donor
结局指标
主要结局
overall survival
progression-free survival
transplant-related mortality
次要结局
- acute GVHD
- chronic GVHD