In-Vivo Activated T-Cell Depletion to Prevent GVHD
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of Patients With Acute Grade II-IV GVHD
研究概览
简要总结
The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease.
This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative ("mini" transplant).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Acute myelogenous leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Chronic lymphocytic leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Mantle cell, Hodgkin's Disease, Multiple Myeloma, Myelofibrosis with disease-specific eligibility requirements as outlined in the protocol
- •Donor Requirement: Must have a fully HLA-matched (10 of 10) related or unrelated donor, eighteen years of age or older, who is capable of undergoing GCSF mobilization and apheresis.
排除标准
- •Active CNS disease (the presence of leukemic blasts in the CSF)
- •Pregnancy or breast-feeding
- •SGOT >3x upper limit of normal
- •Creatinine >2 or creatinine clearance <50cc/hr.
- •Fractional shortening by echocardiogram not within normal limits per institution
- •Pulmonary function: DLCO less that 50% of normal predicted, corrected for anemia
- •Prior allogeneic transplant
结局指标
主要结局
Number of Patients With Acute Grade II-IV GVHD
时间窗: until 30 days after stem cell transplant
Number of patients with Grade II-IV GVHD according to NMDP/CIBMTR GVHD severity scale. This scale measures the degree of GVHD involvement in the patient's skin (inflammatory skin disease), liver (bilirubin levels) and intestinal tract (amount of diarrhea) as well as the level of decline in a patient's activity and physical abilities.
次要结局
- Time to Resolution of Cytopenias: Platelet Transfusion Independence(From Day -1 (day before stem cell infusion) to Day +20 (20 days after stem cell infusion))
- Patients Who Experience Serious Transplant Related Toxicities as Evaluated by Bone Marrow Transplant-adjusted NCI Common Toxicity Criteria.(up to 2 years after stem cell transplant)
- Number of Days for Absolute Neutrophil Count to Recover(From Day -1 (day before stem cell infusion) to Day+20 (20 days after stem cell infusion))
- Number of Patients Engrafting at Day +30 by Short Tandem Repeat (STR) on Peripheral Blood Mononuclear Cells (PBMC's).(until 30 days after stem cell transplant)