A Phase I/II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant.
详细描述
Objectives: I. To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant. II. To determine if the addition of Rituxan changes the toxicity profile attributed to high-dose BEAM chemotherapy.
This protocol is a phase I/II trial combining the Rituxan as a pre and post-transplant agent to aid in the chemotherapy sensitization and the treatment of minimal residual disease 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any low-grade B-cell, CD20 positive, non-Hodgkin's lymphoma that is felt to otherwise be a transplant candidate (relapsed, induction failure, first PR or CR).
- •o Small lymphocytic, marginal zone, mantle cell, and follicular histologies.
- •At least 19 years of age
- •Signed written informed consent
- •Expected survival of at least 6 months
- •WHO performance status greater or equal to 2
- •Male or female subjects of reproductive potential who are able to follow accepted birth control measures.
排除标准
- •No history of T-cell lymphoma
- •Not pregnant or lactating women
- •No serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study
研究组 & 干预措施
Arm I Rituxan and BEAM post-autologous stem cell transplant
Rituxan and BEAM [Carmustine (BCNU), Etoposide, Cytarabine (Ara-C, cytosine arabinoside), Melphalan] will be a pre- and post-transplant agent to aid in the chemotherapy sensitization post-autologous stem cell transplant.
干预措施: Rituxan (Drug)
Arm I Rituxan and BEAM post-autologous stem cell transplant
Rituxan and BEAM [Carmustine (BCNU), Etoposide, Cytarabine (Ara-C, cytosine arabinoside), Melphalan] will be a pre- and post-transplant agent to aid in the chemotherapy sensitization post-autologous stem cell transplant.
干预措施: BEAM (Drug)
Arm I Rituxan and BEAM post-autologous stem cell transplant
Rituxan and BEAM [Carmustine (BCNU), Etoposide, Cytarabine (Ara-C, cytosine arabinoside), Melphalan] will be a pre- and post-transplant agent to aid in the chemotherapy sensitization post-autologous stem cell transplant.
干预措施: Autologous stem cell transplant (Procedure)
结局指标
主要结局
Response rate
时间窗: 100 day
Disease response at day 100
次要结局
- Overall survival(diagnosis until death)