Enhancement of Hematopoietic Stem Cell Engraftment by Multi Donor Stem Cell Transplantation (MDT) From 2 Mismatched Donors, a Phase I-II Open Study
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Day of neutrophil engraftment
研究概览
简要总结
The proposed research focuses on the development of innovative protocol of mismatched stem cell transplantation with combined 2 different haplo stem cell transplantation (SCT) donors which are mismatched to the recipient (and preferably to each other), in a patient in need for SCT, lacking an HLA match related or an unrelated donor. This innovative protocol named multi donor stem cell transplantation (MDT) is designed to facilitate engraftment even when reduced intensity conditioning or a low cell dose are used, improve the graft vs. leukemia (GVL) effect and enhance immune reconstitution (using quantitative and qualitative parameters).
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
- •Patient age 0-70 years old with leukemia in 1st remission at high risk of relapse because of unfavorable prognostic features, at 2nd CR or MDS without an readily available matched donor (related or unrelated).
- •Patients must have a mismatched donor willing and capable of donating peripheral blood stem cells and/or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (mismatched defined as 3/6-4/6 HLA matching).
- •Each patient / patient's guardian must sign written informed consent.
- •Patients must have an ECOG PS ≤ 2; Creatinine <2.0 mg/dl; Ejection fraction >40%; DLCO >50% of predicted; Serum bilirubin <3 gm/dl; elevated GPT or GOT <3 x normal values.
排除标准
- •Not fulfilling any of the inclusion criteria.
- •Not in CR (if the indication for transplant is leukemia).
- •Active life-threatening infection.
- •Overt untreated infection.
- •HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
- •Pregnant or lactating women.
- •Donor contraindication (HIV seropositive confirmed by Western Blot, Hepatitis B antigenemia, HCV, evidence of bone marrow disease, unable to donate bone marrow or peripheral blood due to concurrent medical condition).
- •Previous autologous or allogeneic stem cell transplantation.
- •Inability to comply with study requirements.
研究组 & 干预措施
treatment
干预措施: Multi donor stem cell transplantation (Procedure)
结局指标
主要结局
Day of neutrophil engraftment
时间窗: 30d
Day of platelet engraftment>20x10(9)L
时间窗: 30
Acute GVHD occurrence>2
时间窗: 100d
Disease free survival
时间窗: 100d
次要结局
- Immune reconstitution(100d)
- Transplant related toxicity(100d)
- Day of platelet engraftment>50x10(9)/L(30d)
- Time of acute GVHD(100d)
- GVHD grade(100d)
- Overall survival(100 days)
- Infections incidence(100d)
- transplant-related mortality(100d)
研究者
SHAPIRA MICHAEL
Prof Shapira
Hadassah Medical Organization