The Use Of Peripheral Blood Stem Cells For Allogeneic Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Toxicity
研究概览
简要总结
RATIONALE: Giving chemotherapy drugs and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying the effectiveness of donor peripheral blood stem cell transplant in treating patients with hematologic cancer.
详细描述
OBJECTIVES:
- Determine the efficacy and safety of allogeneic peripheral blood stem cell transplantation in achieving engraftment in patients with hematologic malignancy.
- Determine the hematopoietic recovery, incidence of chemoradiotherapeutic toxicity, relapse, graft-versus-host disease, and survival of patients treated with this regimen.
OUTLINE: Patients receive a preparative chemoradiotherapeutic regimen and graft-versus-host disease prophylaxis prior to transplantation. Patients undergo allogeneic peripheral blood stem cell transplantation on day 0.
Patients are followed every 1-2 weeks for 6 months and at 9, 12, 24, and 36 months.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 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
结局指标
主要结局
Toxicity
时间窗: 6 months
Number of irreversible severe (grade 3) or life-threatening or lethal (grade 4-5) organ toxicities.
Time to engraftment
时间窗: 6 months
Days from infusion of stem cells to recovery of PMN \> 500/ul for two consecutive determinations, transfusion independence for platelets (\>20,000/ul) and RBCs (Hct \> 25%). The bone marrow function is considered durable if reconstitution persists for at least 6 months.
次要结局
- Survival rate(6 months)
- Clinical response(6 months)
- Time to treatment failure and relapse(6 months)
- Number of participants with Graft-versus-host disease(6 months)
研究者
David Savage
Professor of Medicine
Columbia University