NCT00299767已完成1 期
Phase I Study of Sequential Cord Blood Transplants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- To evaluate the 100-day transplant-related (non-relapse) mortality, including relapse-related mortality associated with Grade 4 toxicity.
研究概览
简要总结
The purpose of this study is to determine the safety of sequential cord blood transplantation (2 cord blood units) for patients who have diseases that are capable of being cured by allogeneic stem cell transplant but do not have a matched family or volunteer unrelated donor.
详细描述
Eligible patients will receive conditioning therapy with fludarabine 30 mg/m2/day x 6 days, melphalan 100 mg/m2/day x 1 day, rabbit antithymocyte globulin 1.5 mg/kg/day x 4 days. GVHD prophylaxis will consist of cyclosporine starting on day -1 and mycophenolate mofetil starting on day 0. Sequential cord blood units will be infused on Day 0.
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
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease Status: NHL, HD, or MM refractory to chemotherapy or relapsed; CLL Rai Stage III/IV, or lymphocyte doubling time of 6 months, or Stage I/II resistant to 2 chemotherapy regimens; AML or ALL in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder
- •Estimated disease-free survival of less than one year
- •ECOG performance status of 0, 1, 2
- •Lack of 6/6 or 5/6 HLA matched related or 6/6 matched unrelated donor, or a donor is not available within the time frame necessary to perform a potentially curative stem cell transplant
- •4/6 or greater HLA A, B, CRB1 cord blood units with a combined nucleated cell dose from of > 3.7 x 10(7) NC/kg
排除标准
- •Cardiac disease: symptomatic congestive hearth failure or RVG or echocardiogram determined left ventricular ejection fraction of < 45%, active angina pectoris, or uncontrolled hypertension
- •Pulmonary Disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO of < 50%
- •Renal disease: serum creatinine > 2.0 mg/dl
- •Hepatic disease: serum bilirubin > 2.0 mg/dl (except in the case of Gilbert's syndrome), SGPT or SGOT > 3 x normal
- •Neurologic disease: symptomatic leukoencephalopathy, active DNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
- •HIV antibody or Hepatitis B surface antigen positivity
- •Uncontrolled infection
- •Pregnancy or breast-feeding mother
结局指标
主要结局
To evaluate the 100-day transplant-related (non-relapse) mortality, including relapse-related mortality associated with Grade 4 toxicity.
时间窗: 3 years
次要结局
- To evaluate the 6 month transplant related (non-relapse) mortality.(3 years)
- To evaluate the days to neutrophil engraftment (ANC > 500).(3 years)
- To evaluate the days of platelet engraftment (platelet count > 20K unsupported).(3 years)
- To evaluate the risk of acute and chronic graft versus host disease.(3 years)
- To evaluate percent donor chimerism - contribution of each cord unit.(3 years)
- To evaluate relapse rate.
- To evaluate transfusion support needed to cord blood transplant recipients.(3 years)
- To evaluate overall survival.
研究者
Karen Ballen
Director, Leukemia Program
Massachusetts General Hospital
研究点 (4)
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