NCT00616954终止3 期
An Investigator Initiated, Prospective, Randomized, Controlled Study in Order to Evaluate the Effect of Anti-thymocyte Globulin (Fresenius ATG) on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical Allogeneic Hematopoietic Stem-cell Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Day of day of neutrophil engraftment (ANC>0.5x10^9/L)
研究概览
简要总结
This study is planned to evaluated whether ATG is needed in haploidentical stem cell transplantation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age 3-70 years old with a disease necessitating allogeneic SCT.
- •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.
- •Active life-threatening infection.
- •Overt untreated infection.
- •Known hypersensitivity to ATG.
- •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; positive HCV antibodies with positive HCV PCR; evidence of bone marrow disease; unable to donate bone marrow or peripheral blood due to concurrent medical condition).
- •Inability to comply with study requirements.
研究组 & 干预措施
1
Experimental
with ATG-F
干预措施: ATG-F (Drug)
结局指标
主要结局
Day of day of neutrophil engraftment (ANC>0.5x10^9/L)
时间窗: 30 days
Day of platelet engraftment >25x10^9/L
时间窗: 30 days
次要结局
- AGVHD occurrence(100 days)
- DFS at 100 days(100 days)
- Day of platelet engraftment >50x10^9/L(100 days)
- TRM(100 days)
- TRT(100 days)
- AGVHD grade(100 days)
- OS(100 days)
- Time to AGVHD(100 days)
- Infections incidence(100 days)
研究者
研究点 (1)
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