Multi-center, Phase II Study to Assess the Safety and Efficacy of Haploidentical Bone Marrow Transplantation Using Reduced Intensity Conditioning(RIC)Regimen and Post-transplant Cyclophosphamide,in Patients With Poor Prognosis Lymphomas
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Procedure activity
研究概览
简要总结
Study to test feasibility and efficacy of T-replete Bone Marrow (BM), infused after a RIC regimen and post-transplantation Cyclophosphamide (Cy), in patients with poor prognosis lymphomas.
详细描述
Allogeneic stem cell transplantation (ALLO) is the treatment of choice for many hematological diseases. However, HLA identical donor (sibling or unrelated) is available for 50-60% of patients and alternative donors are needed. Haploidentical donors have been used for many years, mostly after extensive T-cell depletion of peripheral stem cell, to avoid Graft Versus Host Disease (GVHD). Recently, promising data have been reported with haploidentical transplantation using T-replete bone marrow (BM) and high-dose cyclophosphamide (Cy) post-transplantation. However, the conditioning regimen did not contain drugs active against hemopathies, enhancing the relapse risk.
In this study, the investigators want to test the feasibility and efficacy of T-replete BM, infused after a RIC regimen and post-transplantation Cy, in patients with poor prognosis lymphoproliferative diseases.
The RIC regimen consisted of modified regimen used in different studies conducted in Italy on behalf GITMO.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Presence of HLA-matched, related donor (HLA-A, -B, -DRB1)
- •Presence of matched unrelated donor (10/10), available on time.
- •Pregnancy or breast-feeding.
- •Evidence of HIV infection or known HIV positive serology.
- •Current uncontrolled bacterial, viral or fungal infection
- •Evidence of progression of clinical symptoms or radiologic findings.
- •Prior allogeneic hematopoietic stem cell transplant.
- •Central Nervous System (CNS) lymphoma localization
研究组 & 干预措施
RIC regimen
Thiotepa, Fludarabine, Cyclophosphamide pre- and post- transplantation.
干预措施: Thiotepa (Drug)
RIC regimen
Thiotepa, Fludarabine, Cyclophosphamide pre- and post- transplantation.
干预措施: Fludarabine (Drug)
RIC regimen
Thiotepa, Fludarabine, Cyclophosphamide pre- and post- transplantation.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Procedure activity
时间窗: 1 year
1-year Progression Free Survival (PFS) to evaluate the activity of the procedure (taking into account an excess of toxicity). It is assumed that at 1-year a proportion of patients progression free of 20% or lower will be considered to be clinically unworthy, whereas a proportion of 40% or higher will be assumed to be of potential interest.
次要结局
- Neutrophils recovery(1 year)
- Platelets recovery(1 year)
- Incidence of graft failure(1 year)
- Cumulative incidence of acute and chronic GVHD(1 year)
- Incidence of infections(1 year)
- Cumulative incidence of relapse/progression(1 year)
- Treatment related mortality (TRM)(1 year)
- Immunological reconstitution(1 year)