Phase II Trial of Tacrolimus and Rapamycin vs. Tacrolimus and Methotrexate as GVHD Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant
研究概览
简要总结
The purpose of this research is to compare the effectiveness of Tacrolimus and Rapamycin to Tacrolimus and Methotrexate in the prevention of severe graft-versus-host-disease. Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). An allogeneic hematopoietic cell transplant is a transplant using bone marrow and blood cells that come from someone other than the patient (a donor).
详细描述
All drugs used in this study have been used in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Methotrexate used in combination are currently used as standard of care in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Rapamycin is a newer combination we are testing to see if it would be better than Tacrolimus and Methotrexate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 16 and ≤ 70
- •Signed informed consent
- •Adequate vital organ function
- •No active infection, or asymptomatic infection well controlled by antibiotic HIV negative by ELISA or RT-PCR [if ELISA is positive and RT-PCR is negative, the ELISA is considered false positive]
- •Hepatitis B and C negative by serology or RT-PCR
- •Performance status: Karnofsky Performance Status Score ≥ 60%.
排除标准
- •Those with any Sorror's co-morbidity factors with score > 3
- •2 or more Sorror's factors with composite score of ≥ 3
研究组 & 干预措施
Tacrolimus / Rapamycin (TAC/RAPA)
Tacrolimus: beginning 3 days before transplant and given for at least 50 days.
Rapamycin: given the day before transplant and continued daily for at least one year.
干预措施: Tacrolimus (TAC) (Drug)
Tacrolimus / Rapamycin (TAC/RAPA)
Tacrolimus: beginning 3 days before transplant and given for at least 50 days.
Rapamycin: given the day before transplant and continued daily for at least one year.
干预措施: Rapamycin (RAPA) (Drug)
Tacrolimus / Methotrexate (TAC/MTX)
Tacrolimus: beginning 3 days before transplant and given for at least 50 days.
Methotrexate: given on days 1, 3, 6 and 11, after transplant.
干预措施: Tacrolimus (TAC) (Drug)
Tacrolimus / Methotrexate (TAC/MTX)
Tacrolimus: beginning 3 days before transplant and given for at least 50 days.
Methotrexate: given on days 1, 3, 6 and 11, after transplant.
干预措施: Methotrexate (MTX) (Drug)
结局指标
主要结局
Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant
时间窗: 100 Days Post Transplant
Incidence of acute graft versus host disease grades 2-3 according to the Common Toxicity Criteria (CTC) version 3. Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). Clinical evidence of acute GVHD was recorded per standard grading scheme. Acute GVHD classified as the following: 1. classic acute GVHD - onset within 100 days after transplant 2. persistent - acute GVHD with onset prior to day 100 and without resolution beyond day 100 3. recurrent - acute GVHD recurrent after prior episode of acute GVHD 4. late acute GVHD - syndrome consistent with acute GVHD, without features of chronic GVHD, with onset occurring beyond 100 days
次要结局
- 2 Year Post Transplant Overall Survival (OS) Rate(2 years)
- Incidence of Increased Absolute Numbers of Regulatory T Cells (Treg)(30 days and 90 days)