HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib Following Fludarbine/Melphalan/Total Body Irradiation Conditioning Regimen
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- engraftment rate
研究概览
简要总结
Now haplo stem cell transplant using bone marrow or peripheral blood is becoming more feasible with better regimens to prevent graft versus host disease (GVHD) like post transplant cyclophosphamide , tacrolimus, mycophenolate . Recently Bortezomib has also been shown to inhibit dendritic cells maturation and function and possesses a number of other favorable immunomodulatory effect that can prevent GVHD and help enhance immune reconstitution. this study is to assess the engraftment rate in patients with hematologic malignancies who need allogeneic stem cell transplant but do not have a suitable matched related or unrelated stem cell donor and will get T-cell replete HLA-Haploidentical allogeneic peripheral stem cell transplantation using post transplant Cyclophosphamide and bortezomib
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (</= 7/8 allele match at the A, B, C, DR loci with a minimum match of 5/10 is required) is identified
- •Candidate for stem cell transplant in a malignant hematological condition
- •Karnofsky Performance Scale 0-1
- •Available donor able to undergo a Peripheral blood stem cells collection
- •Bilirubin </= 1.5 mg/dl , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) </= 200 IU/ml for adults.
- •Serum creatinine clearance >/=60 ml/min (calculated with Cockroft-Gault formula)
- •Diffusing capacity for carbon monoxide (DLCO) >/= 45% predicted corrected for hemoglobin.
- •Left ventricle ejection fraction > 40%.
- •Patient or patient's legal representative, parent(s) or guardian should provide written informed consent.
排除标准
- •Adult who has a suitable related or unrelated donor or cord units available for transplant. Suitable donors include 8/8 (HLA-A,B,C and DR, with all loci high-resolution typing) or 7/8 related or unrelated donor available within 42 days of search initiation
- •HIV positive; active hepatitis B or C
- •Patients with active uncontrolled infections.
- •Liver cirrhosis
- •Uncontrolled central nervous system involvement by tumor cells
- •Positive Beta Human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- •Inability to comply with medical therapy or follow-up
研究组 & 干预措施
Bortezomib
干预措施: Bortezomib (Drug)
结局指标
主要结局
engraftment rate
时间窗: within 30 days post transplant
rate of neutrophil and platelet engraftment post stem cell transplant
次要结局
未报告次要终点
研究者
Shatha Farhan
Principal Investigator
Henry Ford Health System