A Phase II Trial of Doxil, Rituximab, Cyclophosphamide, Vincristine, and Prednisone (DR-COP) in Patients With Newly Diagnosed AIDS-Associated B-Cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 14
- 主要终点
- Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving combination chemotherapy together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with newly diagnosed AIDS-related B-cell non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the complete response rate (complete response and complete response unconfirmed) in patients with newly diagnosed, AIDS-related B-cell non-Hodgkin's lymphoma treated with doxorubicin hydrochloride liposome, rituximab, cyclophosphamide, vincristine, and prednisone (DR-COP).
- Determine the duration of response (relapse-free survival) in patients treated with this regimen.
- Determine the median survival time of patients treated with this regimen.
- Determine rate of bacterial, fungal, and opportunistic infections in patients treated with this regimen.
Secondary
- Determine, preliminarily, the relationship between MDR-1 expression in tumor tissue and response to therapy in patients treated with this regimen.
- Determine, preliminarily, any relationship between response and survival and BCL-2 expression in tumor tissue in patients treated with this regimen.
- Determine any relationship between development of bacterial, fungal, and/or opportunistic infections and baseline CD4 lymphocyte count, HIV-1 RNA level, and quantitative immunoglobulin levels, or changes in quantitative immunoglobulin levels over time in patients treated with this regimen.
- Compare the results of positron emission tomography (PET) scanning with traditional CT scans in predicting response to therapy in these patients.
- Examine the relationship between chemotherapeutic drug levels and receipt of specific antiretroviral and/or anti-infective medications in these patients.
- Examine the mortality and the causes of death in patients treated with this regimen.
- Determine event-free survival at 1 year.
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 120 Years（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
DR-COP
Single arm interventional study: all subjects receive DR-COP regimen.
干预措施: rituximab (Biological)
DR-COP
Single arm interventional study: all subjects receive DR-COP regimen.
干预措施: vincristine sulfate (Drug)
DR-COP
Single arm interventional study: all subjects receive DR-COP regimen.
干预措施: filgrastim (Biological)
DR-COP
Single arm interventional study: all subjects receive DR-COP regimen.
干预措施: pegfilgrastim (Biological)
DR-COP
Single arm interventional study: all subjects receive DR-COP regimen.
干预措施: sargramostim (Biological)
DR-COP
Single arm interventional study: all subjects receive DR-COP regimen.
干预措施: cyclophosphamide (Drug)
DR-COP
Single arm interventional study: all subjects receive DR-COP regimen.
干预措施: pegylated liposomal doxorubicin hydrochloride (Drug)
DR-COP
Single arm interventional study: all subjects receive DR-COP regimen.
干预措施: prednisone (Drug)
DR-COP
Single arm interventional study: all subjects receive DR-COP regimen.
干预措施: immunohistochemistry staining method (Other)
DR-COP
Single arm interventional study: all subjects receive DR-COP regimen.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Complete Response Rate (Complete Response and Complete Response Unconfirmed) Defined as Disappearance of All Evidence of Disease Based on Radiographic Findings on CT or MRI .
时间窗: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
Duration of Response
时间窗: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
Rate of Bacterial, Fungal, and Opportunistic Infections
时间窗: After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
Median Survival Time
时间窗: After cycles 2, 4, 6, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation
次要结局
- Relationship Between MDR-1 Expression and Response to Treatment(Baseline)
- Relationship Between Response and Survival and BCL-2 Expression in Tumor Tissue(Baseline, after cycles 4 and 6, 1 month after treatment discontinuation)
- Relationship Between Development of Bacterial, Fungal, and/or Opportunistic Infections and Baseline CD4 Lymphocyte Count, HIV-1 RNA Level, and Quantitative Immunoglobin Level, or Changes in Quantitative Immunoglobin Levels Over Time(After every cycle of treatment, 1 month after treatment discontinuation, every 2 months for 1 year after treatment discontinuation, every 6 months during the second and third years after treatment discontinuation)
- Mortality and Cause of Death(At any time through the third year after treatment discontinuation)
- Event-free Survival at 1 Year(1 year post-treatment)