Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Relationship Between Marker Detection and Clinical Outcome
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as 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 work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Investigate plasma DNA biomarkers, including plasma clonal immunoglobulin DNA, tumor suppressor gene methylation, and Epstein-Barr virus DNA, in patients receiving rituximab and doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD) for newly diagnosed stage II-IV classical Hodgkin's lymphoma.
- Characterize the impact of rituximab on these markers.
- Characterize the relationship between marker detection and clinical outcome.
Secondary
- Estimate the event-free survival of patients with newly diagnosed Hodgkin's lymphoma treated with rituximab and ABVD.
- Assess the presence of Hodgkin's lymphoma stem cells in peripheral blood mononuclear cells at baseline, after treatment with rituximab, and after treatment with ABVD.
- Assess whether plasma DNA biomarkers add information to fludeoxyglucose F 18 positron emission tomography (FDG-PET) in assessing tumor response.
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
R-ABVD
ABVD (doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
干预措施: Bleomycin (Drug)
R-ABVD
ABVD (doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
干预措施: Vinblastine (Drug)
R-ABVD
ABVD (doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
干预措施: Rituximab (Biological)
R-ABVD
ABVD (doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
干预措施: Dacarbazine (Drug)
R-ABVD
ABVD (doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
干预措施: Doxorubicin (Drug)
结局指标
主要结局
Relationship Between Marker Detection and Clinical Outcome
时间窗: 3 years
Number of relapses for participants who did and did not have re-emergence of clonal CD27(+) ALDH(+) B cells after completing study intervention.
Effect of Rituximab on EBV(+) Tumors
时间窗: Up to 56 months
Number of relapses among participants who had tumors positive for Epstein-Barr virus (EBV).
次要结局
- Event-free Survival(3 years)
- Addition of Information to Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Plasma DNA Biomarkers(5 years)