Allogeneic Transplantation in Patients With Myelodysplastic Syndrome Based on Risk According to Revised-International Prognostic Scoring System (R-IPSS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- overall survival
研究概览
简要总结
An "intention-to-treat" study to evaluate the impact of allogeneic HSCT with Total Marrow and Lymphoid irradiation (TMLI), followed by Treg/Tcon adoptive immunotherapy, on overall survival in patients affected by Myelodysplastic Syndrome (MDS), according to IPSS-R.
详细描述
MDS patients with Intermediate, High, or Very-High R-IPSS risk will be enrolled. Allogeneic stem cell transplantation with regulatory and conventional T cell adoptive immunotherapy will be proposed to eligible High and Very-High risk MDS patients. Intermediate risk MDS patients will be assessed for risk modification every six months and moved to transplant in case of increased risk. Intermediate risk MDS patients will be also evaluated for the presence of molecular alterations (TP53, ASXL1, RUNX1). Overall survival of the entire cohort will be assessed as primary endpoint. Incidence of Treatment Related Mortality, acute Graft versus Host Disease, chronic Graft versus Host Disease, Relapse will be also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients affected by Myelodysplastic Syndrome with IPSS-R INT, HIGH or VERY HIGH;
- •Age <71 years;
- •Signature of the informed consent.
排除标准
- •Patients affected by Myelodysplastic Syndrome with IPSS-R VERY LOW or LOW;
- •Patients affected by Myelodysplastic Syndrome/Myeloproliferative Neoplasm;
- •Age >70 years;
- •No signature of the informed consent
结局指标
主要结局
overall survival
时间窗: 4 years
We will evaluate overall survival in patients with intermediate/High/very-High risk MDS
次要结局
未报告次要终点
研究者
Andrea Velardi
FULL PROFESSOR
University Of Perugia