A Non-Myeloablative Conditioning Regimen With Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With B Cell Lymphoid Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Survival at 1 Year After Transplantation
研究概览
简要总结
RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, total-body irradiation, and rituximab before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy together with rituximab and an umbilical cord blood transplant works in treating patients with B-cell non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the overall and event-free survival at 1 year in patients with B-cell lymphoid malignancies treated with a nonmyeloablative conditioning regimen, rituximab, and umbilical cord blood (UCB) transplantation (UCBT).
Secondary
- Determine the speed of neutrophil and platelet recovery post allograft in these patients.
- Determine the incidence and speed of donor-derived engraftment and contribution of each UCB unit to engraftment in these patients.
- Determine the incidence and severity of acute graft-vs-host disease (GVHD) at 100 days in these patients.
- Determine the incidence and severity of chronic GVHD at 1 year in these patients.
- Determine the incidence of serious infectious complications and correlate with laboratory measurements of immune recovery in these patients.
- Determine the response to vaccination after UCBT in these patients.
- Determine the incidence of treatment-related mortality at 100 days and 180 days in these patients.
- Determine the incidence of malignant relapse or disease progression at 1 and 2 years in these patients.
- Determine the probabilities of overall and event-free survival at 2 years after UCBT in these patients.
- Determine the performance of laboratory studies investigating double-unit biology and correlate with unit engraftment in these patients.
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 70 Years（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
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
干预措施: filgrastim (Biological)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
干预措施: rituximab (Biological)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
干预措施: cyclophosphamide (Drug)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
干预措施: cyclosporine (Drug)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
干预措施: fludarabine phosphate (Drug)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
干预措施: mycophenolate mofetil (Drug)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
干预措施: allogeneic hematopoietic stem cell transplantation (Procedure)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
干预措施: umbilical cord blood transplantation (Procedure)
Unrelated Donor Umbilical Cord Transplant
Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
干预措施: total-body irradiation (Radiation)
结局指标
主要结局
Survival at 1 Year After Transplantation
时间窗: 1 Year after transplant
The number of patients survival status 1 year after transplantation
次要结局
未报告次要终点