A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 159
- 主要终点
- Event-free Survival After 12 Months
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.
详细描述
OBJECTIVES:> Primary>
- Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month, event-free survival, in patients with previously untreated stage II, III, or IV diffuse large B-cell lymphoma.>
- Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.>
- Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this regimen.>
- Assess the safety of this treatment regimen.> Secondary>
- Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen.> OUTLINE: This is a multicenter study.> Patients receive epratuzumab IV over 1 hour on day 1, rituximab IV over 4-8 hours on day 1 or days 1 and 2, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 or 2, and oral prednisone on days 1-5 or 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.> After completion of study treatment, patients are followed periodically for up to 5 years.> PROJECTED ACCRUAL: A total of 86 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Epratuzumab + Rituximab + CHOP
One arm open label.
干预措施: epratuzumab (Biological)
Epratuzumab + Rituximab + CHOP
One arm open label.
干预措施: rituximab (Biological)
Epratuzumab + Rituximab + CHOP
One arm open label.
干预措施: cyclophosphamide (Drug)
Epratuzumab + Rituximab + CHOP
One arm open label.
干预措施: doxorubicin hydrochloride (Drug)
Epratuzumab + Rituximab + CHOP
One arm open label.
干预措施: prednisone (Drug)
Epratuzumab + Rituximab + CHOP
One arm open label.
干预措施: vincristine sulfate (Drug)
结局指标
主要结局
Event-free Survival After 12 Months
时间窗: From Baseline to 12 months
The primary endpoint of the trial was the percentage of the eligible patients who were alive and event-free 12 months after enrollment to the study (EFS12).
次要结局
- Overall Survival(time from study entry to 36 months)
- Overall Response Rate (ORR)(Baseline to first 6 cycles of treatment)
- Progression-free Survival (PFS)(the time from study entry to 36 months)