Randomized Trial Comparing Autologous Peripheral Blood Stem Cell Transplantation to Bone Marrow Transplantation for Patients Receiving High-Dose Chemotherapy and Transplantation for Recurrent Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Percentage of Participants with Relapse
研究概览
简要总结
The purpose of this study is to evaluate the difference in relapse rates and long term event free survival in patients with intermediate grade or immunoblastic non-Hodgkin's lymphoma (NHL) whose marrow is not obviously involved with NHL who are randomized to receive either an autologous bone marrow (ABMT) or peripheral stem cell transplant (PSCT). All patients with intermediate grade NHL with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and ABMT are eligible for this study. Patients who are eligible will be randomized to either PSCT or ABMT at the time of enrollment into our transplant program.
详细描述
These patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue. The patients will be stratified according to good and poor prognosis category and relapsed vs. first partial response categories. The patients will have bone marrow or peripheral stem cells collected according to standard protocols. A standardized hematopoietic growth factor will be used for mobilization and post-transplant. The patients' PSC or bone marrow (BM) product will be assayed via invitro-culture techniques for occult tumor, and by molecular biologic assays. The patients' outcome for transplantation will be evaluated with response to transplantation, relapse rates and event free survival being the measured end points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16-65
- •Intermediate grade non-Hodgkin's lymphoma (International Working Formulation - Follicular large cell, Diffuse Small Cleaved, Diffuse Mixed, Diffuse Large Cell, and Immunoblastic) with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and ABMT. These criteria are in each specific high-dose therapy protocol (i.e. Karnofsky performance status > 70, adequate organ function, HIV and Hepatitis B negative, etc.). These patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue.
排除标准
- •Patients with bone marrow histologically involved with tumor or with a bone marrow abnormality making bone marrow harvest not possible.
- •Patients whose tumor is rapidly growing which may preclude the extra time involved with the PSC collection process.
- •Patients who do not otherwise meet high-dose therapy and transplantation entry criteria.
结局指标
主要结局
Percentage of Participants with Relapse
时间窗: From date of transplant until death (up to 220 months)
Percentage of participants with recurrence (return of cancer)
New Blood Cell Production Response
时间窗: From date of transplant until death (up to 220 months)
Production of new blood cells after transplantation
Percentage of participants with event free survival
时间窗: From date of transplant until death (up to 220 months)
Percentage of participants with event free survival (no relapse or progression)
次要结局
未报告次要终点