Clinical Trial Of C2B8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Event-free Survival (EFS)
研究概览
简要总结
Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects.
This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy.
Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.
详细描述
The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375 mg/m2, starting 6 weeks after ASCT transplant.
After an observation period to assess acute and late toxicity for the first 4 subjects, subsequent subjects received induction as above followed by an additional 4 week course at 6-months post-ASCT.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •B-cell, CD20+ NHL
- •Evidence of engraftment post-autologous peripheral blood stem cell transplant (PBSC-T), aka autologous stem cell transplant (ASCT)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- •Creatinine < 2 mg/dL
- •Bilirubin < 2.0 mg/dL
- •Liver function tests (LFTs) < 5 x upper limit of normal (ULN)
排除标准
- •Graft source from bone marrow
- •Non-responders [progressive disease (PD) or stable disease (SD)] to prior anti-CD20 therapy
- •PD after ASCT
- •Post-ASCT radiotherapy
- •Concomitant treatment with radiotherapy, chemotherapy or immunotherapy including rituximab
- •Evidence of active pneumonitis
- •Evidence of active infection
- •Concurrent prednisone or other systemic steroid medication
- •Nitrosourea therapy within 6 weeks of the first treatment with rituximab
- •Presence of anti-murine antibody (HAMA) reactivity
研究组 & 干预措施
Rituximab after ASCT
Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT.
干预措施: Rituximab 375 mg/m2 (Drug)
结局指标
主要结局
Event-free Survival (EFS)
时间窗: 24 months
"Events" for EFS were defined as the earlier of post-ASCT relapse or death.
次要结局
- Overall Survival (OS)(24 months)