Pilot Study Of Multiple Umbilical Cord Blood Unit Transplantation Following Non-Myeloablative Conditioning In Patients With Hematologic Disorders Or Severe Aplastic Anemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Event-free survival by disease assessment
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Umbilical cord blood transplantation may be able to replace cells destroyed by chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by umbilical cord blood transplantation in treating patients who have hematologic cancer or severe aplastic anemia.
详细描述
OBJECTIVES:
- Determine the incidence and severity of acute toxicity in patients with hematologic malignancies or severe aplastic anemia treated with a non-myeloablative conditioning regimen followed by umbilical cord blood transplantation.
- Determine the incidence and severity of acute and chronic graft-versus-host-disease in patients treated with this regimen.
- Determine the incidence of relapse, disease-free survival, and overall survival of patients treated with this regimen.
- Determine the survival rate at 100 days post-transplantation in patients treated with this regimen.
- Determine the incidence of regimen-related complications (infection, hepatic veno-occlusive disease, and interstitial pneumonitis) in patients treated with this regimen.
- Determine the incidence of primary and secondary graft failure in patients treated with this regimen.
- Determine the rates and kinetics of donor-derived lymphoid, myeloid, neutrophil, RBC, and platelet engraftment in patients treated with this regimen.
OUTLINE: Patients receive a non-myeloablative conditioning regimen comprising fludarabine IV over 30 minutes on days -8 to -4, cyclophosphamide IV over 2 hours on days -3 to -2, and anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1. Patients unable to tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1.
Patients undergo multiple unit umbilical cord blood transplantation on days 0-1. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood counts recover.
Patients are followed monthly for 6 months; at 9, 12, 14, 16, 18, and 24 months; and then annually thereafter.
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
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
non-myeloablative conditioning regimen
干预措施: umbilical cord blood transplantation (Procedure)
non-myeloablative conditioning regimen
干预措施: anti-thymocyte globulin (Biological)
non-myeloablative conditioning regimen
干预措施: filgrastim (Biological)
non-myeloablative conditioning regimen
干预措施: cyclophosphamide (Drug)
non-myeloablative conditioning regimen
干预措施: fludarabine phosphate (Drug)
non-myeloablative conditioning regimen
干预措施: methylprednisolone (Drug)
结局指标
主要结局
Event-free survival by disease assessment
时间窗: at 28 and 100 days and then at 6, 9, 12, 18, and 24 months
次要结局
- Umbilical cord blood donor engraftment by chimerism and complete blood count (CBC)(monthly for 6 months and then at 9, 12, 18, and 24 months)