Treatment of B-Cell NHL Relapsing After Transplant With a Rituxan Vinorelbine Combination
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Tolerability and toxicity
研究概览
简要总结
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab plus chemotherapy with vinorelbine in treating patients with B-cell non-Hodgkin's lymphoma that has relapsed following autologous peripheral stem cell transplantation.
详细描述
OBJECTIVES:
- Determine the tolerability and toxicity of rituximab combined with vinorelbine in patients with relapsed non-Hodgkin's lymphoma following autologous peripheral blood stem cell transplantation.
- Assess the response rate and duration of response to this regimen in these patients.
OUTLINE: Patients receive rituximab IV weekly on weeks 1-4, 6, 8, 10, and 12 and vinorelbine IV on weeks 2-4, 6-8, and 10-12. Patients who achieve partial response may continue on vinorelbine from week 14 until disease progression.
Patients are followed until disease progression.
PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with B-cell Lymphoma, relapsing after high dose chemotherapy and autologous stem cell transplantation or allogeneneic stem cell or bone marrow transplant
- •Age > 18 years old
- •Adequate hematologic function, as manifested by ANC > 1000/mm3 and platelet count > 40,000/mm3
- •PS WHO: < 3
排除标准
- •Patients with serum creatinine > 2 mg%, transaminases (ALT, AST) > 3 times upper normal value, direct bilirubin > 2 mg%, unless they result from tumor involvement
- •Pregnant or lactating females
- •History of myelodysplastic syndrome
- •Uncontrolled CNS disease
- •Active serious infection
- •History of refractoriness to vinorelbine. However, prior treatment with rituxan is not an exclusion (synergy may still occur)
研究组 & 干预措施
Vinorelbine and Rituxan
Week 1-4: Rituxan is given at 375 mg/m2 weekly x4. Vinorelbine (25mg/m2) given 1 week after the first rituxan dose and immediately after the second rituxan dose.
Week 5-8: Rituxan given every 2 weeks. Vinorelbine given weekly x3, with one week off.
Week 9-12: Schedule same as week 5-8. Week 13 and following: If subject doesn't have disease progression, they may continue on Vinorelbine until progression or until clinically indicated.
干预措施: rituximab (Biological)
Vinorelbine and Rituxan
Week 1-4: Rituxan is given at 375 mg/m2 weekly x4. Vinorelbine (25mg/m2) given 1 week after the first rituxan dose and immediately after the second rituxan dose.
Week 5-8: Rituxan given every 2 weeks. Vinorelbine given weekly x3, with one week off.
Week 9-12: Schedule same as week 5-8. Week 13 and following: If subject doesn't have disease progression, they may continue on Vinorelbine until progression or until clinically indicated.
干预措施: vinorelbine ditartrate (Drug)
结局指标
主要结局
Tolerability and toxicity
时间窗: 13 weeks
To define the tolerability and toxicity of a combination regimen of rituxan combined with vinorelbine for the treatment of B-cell NHL, relapsing after autologous stem cell transplantation.
次要结局
- Response rate(13 weeks)