IIT2021-11-PAQUETTE-OmitMMF: Fludarabine and Total Body Irradiation 800 cGy or 1125 cGy For Allogeneic Stem Cell Transplant Using Graft Versus Host Disease Prophylaxis With Post-Transplant Cyclophosphamide and Tacrolimus, Without Mycophenolate Mofetil
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Engraftment failure
研究概览
简要总结
This is a pilot study to evaluate the feasibility, safety and potential benefits of removing one immune suppressive drug called mycophenolate mofetil (MMF) from the standard allogenic stem cell transplant treatment protocol.
MMF will be omitted from the transplant regimen in 60 eligible patients with hematologic malignancies. Participants will be followed for up to 2 years post standard of care transplant at Cedars-Sinai.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age 18-75 years
- •Patient has a related donor who is at least Human Leukocyte Antigen (HLA) haploidentical, or an unrelated donor who is a most a single HLA antigen mismatch.
- •Patient signs the Informed Consent Form for the study
- •Patient has a hematologic malignancy other than myelofibrosis and meets standard criteria for allogeneic stem cell transplant.
- •Patient is deemed suitable to receive Fludarabine and Total Body Irradiation (Flu/TBI) 1125 or Flu/TBI 800 conditioning regimen as standard of care transplant
- •Donor is willing to donate peripheral blood stem cells
排除标准
- •Patient has a diagnosis of myelofibrosis
- •Patient has high titer antibodies against one or more donor HLA antigens
- •Patient has undergone prior autologous or allogeneic stem cell transplant.
- •Inability to collect sufficient peripheral blood stem cells from the donor
研究组 & 干预措施
Open Arm
Omission of the drug mycophenolate mofetil
干预措施: Omission of the drug mycophenolate mofetil (Other)
结局指标
主要结局
Engraftment failure
时间窗: 60 days post-transplant
Evaluate the feasibility of eliminating the drug Mycophenolate Mofetil (MMF) from the transplant regimens as determined by an acceptable rate of engraftment failure (\<10%). Engraftment failure is when the blood-forming cells received on transplant day do not start to grow and make healthy blood cells.
次要结局
- Relapse(1 year post-transplant and 2 years post-transplant)
- Time to neutrophil and platelet engraftment(60 days post-transplant)
- Treatment-related mortality(5 days post- transplant to 2-years)
- Rate of severe acute GVHD by day +100.(100 days post-transplant)
- Overall Survival (OS)(1-year post-transplant and 2-years post-transplant)
- Graft Versus Host Disease (GVHD)-free, Relapse Free Survival(1-year post- transplant and 2-years post-transplant)
- Rate of severe chronic GVHD at 1 year(1-year post-transplant)
研究者
Ronald Paquette
Medical Director, Blood and Marrow Transplant Program
Cedars-Sinai Medical Center