Phase II Trial Of Non-Myeloablative Regimen Combining Melphalan, Fludarabine, And Anti-CD52 Monoclonal Antibody (CAMPATH-1H) Followed By An Unmodified Hematopoietic Cell Transplant From An HLA Compatible Related Or Unrelated Donor For Treatment Of Lymphohematopoietic Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Giving low doses of chemotherapy, such as melphalan and fludarabine, and a monoclonal antibody, such as alemtuzumab, before a donor bone marrow or peripheral 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 system 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 after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well fludarabine, melphalan, alemtuzumab, and peripheral stem cell transplant work in treating patients with hematologic cancer.
详细描述
OBJECTIVES:
Overall survival-12 months
Overall survival-24 months
Acute Graft-versus-Host Disease Matched Related patients-up to 4 months post transplant
Acute Graft-versus-Host Disease Unrelated and Mismatched related patients- up to 4 months post transplant
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 70 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
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
干预措施: alemtuzumab (Biological)
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
干预措施: cyclosporine (Drug)
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
干预措施: fludarabine phosphate (Drug)
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
干预措施: melphalan (Drug)
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
干预措施: allogeneic bone marrow transplantation (Procedure)
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES
This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
干预措施: peripheral blood stem cell transplantation (Procedure)
结局指标
主要结局
Overall Survival
时间窗: 24 months post transplant
Acute Graft-versus-Host Disease Matched Related Patients
时间窗: up to 4 months post transplant
Grade III-IV Acute Graft-versus-Host Disease
次要结局
- Acute Graft-versus-Host Disease Unrelated and Mismatched Related Patients(up to 4 months post transplant)
- Extensive Chronic Graft-versus-Host Disease Matched Related Patients(up to 2 years post transplant)
- Extensive Chronic Graft-versus-Host Disease Unrelated and Mismatched Related Patients(up to 2 years post transplant)