Early Use of Tacrolimus in HLA-Mismatched Haploidentical Allogeneic Hematopoietic Transplantation With Post-Transplant Cyclophosphamide
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Efficacy in preventing CRS post transplant
研究概览
简要总结
To evalute the safety and efficacy in reducing Cytokine Release Syndrome after hematopoietic stem cell transplantation by introducing immunosuppression earlier in the transplant process
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Availability of a 5/10-8/10 mismatched (HLA-A, B, DR) haploidentical related donor with a negative HLA cross-match in the host vs. graft direction and willing to provide peripheral blood stem cells
- •Karnofsky status >/= 70%
- •Hematologic malignancy requiring allogeneic transplantation
- •First allogeneic transplant only. Prior autologous transplant is allowed.
排除标准
- •Poor cardiac function: LVEF <40%
- •Poor pulmonary function: FEV1 and FVC <50% predicted
- •Poor liver function: bilirubin >/= 3mg/dL (not due to hemolysis, Gilbert's or primary malignancy)
- •Poor renal function: Creatinine >/= 2mg/dL or creatinine clearance (calculated or measured creatinine clearance is permitted) <40mL/min based on Traditional Cockcroft-Gault formula
- •Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
- •Patients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow up
研究组 & 干预措施
Tacrolimus + MMF + Post-Transplant Cyclophosphamide
Cyclophosphamide 50mg/kg/d Days +3 and +4 after transplant Tacrolimus Day -1 to Day +90 or Day +180 after transplant MMF 15mg/kg PO TID Day 0 to Day +35
干预措施: Mycofenolate mofetil (Drug)
Tacrolimus + MMF + Post-Transplant Cyclophosphamide
Cyclophosphamide 50mg/kg/d Days +3 and +4 after transplant Tacrolimus Day -1 to Day +90 or Day +180 after transplant MMF 15mg/kg PO TID Day 0 to Day +35
干预措施: Tacrolimus (Drug)
Tacrolimus + MMF + Post-Transplant Cyclophosphamide
Cyclophosphamide 50mg/kg/d Days +3 and +4 after transplant Tacrolimus Day -1 to Day +90 or Day +180 after transplant MMF 15mg/kg PO TID Day 0 to Day +35
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Efficacy in preventing CRS post transplant
时间窗: 30 days
Evaluate the incidence of CRS during the first 5 days following stem cell transplant by recording signs and symptoms based on CTCAE v5.0.
次要结局
- Severity of CRS after stem cell transplant(30 days)
- Safety of administering early immunosuppression(1 year)
- Safety of administering early immunosuppression(6 months)