Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) a 12 months from the enrollment higher than 30% for the patients submitted to allogeneic stem cell transplantation in front of the patients who received conventional chemotherapy.
研究概览
简要总结
This is a perspective multicentric study for the treatment of patients aged equal or less than 60 years and submitted to an allogeneic hematopoietic stem cell transplantation from an HLA compatible related or unrelated donor because affected by resistent or refractory or relapsed after autologous stem cell transplantation Ewing Sarcoma or Soft tissues sarcoma who did not benefit from conventional therapy.
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
- 1 Month 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-60 years.
- •Performance status according to Karnofsky score > 70%
- •Normal liver function
- •Normal renal function
- •Normal cardiac function
- •Informed consent
- •Availability of an HLA compatible Donor
排除标准
- •Absence of at least one of the inclusion criteria
研究组 & 干预措施
Stem Cell Transplant
All the patient who are affected by refractory or resistant or relapsed Soft tissue sarcoma o Ewing sarcoma who find an HLA compatible allogeneic donor and are submitted to Stem cell transplantation
干预措施: Allogeneic hemopoietic stem cell transplant (Procedure)
结局指标
主要结局
Progression Free Survival (PFS) a 12 months from the enrollment higher than 30% for the patients submitted to allogeneic stem cell transplantation in front of the patients who received conventional chemotherapy.
时间窗: 12 months from the enrollement
次要结局
- Transplant related mortality(12 months after the enrollement of the first patients)