A Randomized Phase III Study Of Chimeric Anti-CD20 Monoclonal Antibody (Rituximab) With 2-Weekly CHOP Chemotherapy In Elderly Patients With Intermediate Or High-Risk Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 400
- 试验地点
- 26
- 主要终点
- Event-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. It is not yet known if combination chemotherapy plus filgrastim is more effective with or without rituximab in treating non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy plus filgrastim with or without rituximab in treating older patients who have non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Compare the efficacy of cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP), and filgrastim (G-CSF) with or without rituximab on event-free survival of elderly patients with intermediate or high-risk non-Hodgkin's lymphoma.
- Compare the complete remission rate, overall survival, and disease-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, WHO classification, and International Prognostic Index score. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5; and filgrastim (G-CSF) subcutaneously on days 1-14. Treatment repeats every 2 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive cyclophosphamide, doxorubicin, vincristine, prednisone, and G-CSF as in arm I. Patients also receive rituximab IV on day 3 of courses 1-2 and on day 1 of courses 3-6 for a total of 6 doses.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-Hodgkin's lymphoma (NHL)
- •Low- or high-intermediate or high-risk lymphoma of any of the following subtypes:
- •Mantle cell lymphoma
- •Follicular lymphoma (grade III)
- •Diffuse large B-cell lymphoma
- •CD20-positive
- •No suspected or documented CNS involvement by NHL NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
- •PATIENT CHARACTERISTICS:
- •65 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin less than 1.75 mg/dL*
- •Transaminases less than 2.5 times normal* NOTE: * Unless due to NHL
- •Creatinine less than 1.7 mg/dL (unless due to NHL)
- •Cardiovascular:
- •No severe cardiac dysfunction
- •No New York Heart Association class II-IV heart disease
- •LVEF at least 45%
- •No uncontrolled asthma requiring steroid treatment
- •HIV negative
- •No intolerance to exogenous protein administration
- •No active, uncontrolled infection
- •No uncontrolled allergy requiring steroid treatment
- •No other malignancy within the past 5 years except basal cell skin cancer or stage 0 cervical cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior immunotherapy for NHL
- •Chemotherapy:
- •No prior chemotherapy for NHL
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy for NHL except local radiotherapy for potential organ dysfunction by localized lymphoma mass or infiltration
- •Concurrent local radiotherapy for potential or actual organ dysfunction by localized lymphoma mass or infiltration allowed
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Event-free survival
次要结局
- Disease-free interval
- Complete response
- Overall survival
- Toxicity