Randomized Phase III Trial Of Rituximab (NSC #687451) And Autologous Stem Cell Transplantation For B Cell Diffuse Large Cell Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 427
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies, such as rituximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether stem cell transplantation is more effective with or without rituximab in treating relapsed or progressive B-cell diffuse large cell lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of stem cell transplantation with or without rituximab in treating patients who have relapsed or progressive B-cell diffuse large cell lymphoma.
详细描述
OBJECTIVES:
- Compare disease-free survival of patients with relapsed or progressive B-cell diffuse large cell lymphoma undergoing stem cell transplantation with or without post-transplant rituximab.
- Evaluate the effect of rituximab, administered post-transplant, on the procedure-related mortality of these patients.
- Determine the potential infectious complications of the addition of this drug to autologous stem cell transplantation in these patients.
- Compare overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to relapse (relapsed more than 6 months after either initial complete remission [CR] or CR with positive positron emission tomography or MRI [gallium] vs failed to achieve initial CR or relapsed within 6 months after either initial CR or CR with positive PET or MRI [gallium]) and prior rituximab (yes vs no).
Stem cell mobilization
- Patients receive rituximab IV over 4-8 hours on days 1 and 5. Patients also receive cyclophosphamide IV over 2 hours on day 8 and filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until the last day of apheresis. Stem cells are collected over 1-3 days.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of diffuse large cell lymphoma and meeting the following criteria:
- •B-cell type with expression of CD20 either at diagnosis or at relapse
- •Relapse after having achieved an initial complete remission (CR) or failure to achieve initial CR (residual radiographic abnormalities after primary therapy allowed if these abnormalities are also positive by positron emission tomography or MRI [gallium])
- •No newly diagnosed disease
- •No progressive or stable disease to most recent salvage therapy
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 2.0 mg/dL
- •AST or ALT < 3 times upper limit of normal
- •Creatinine ≤ 2.0 mg/dL OR
- •Creatinine clearance ≥ 40 mL/min
- •Cardiovascular
- •Cardiac ejection fraction ≥ 40%
- •DLCO ≥ 60% of predicted
- •No other malignancy within the past 2 years except basal cell skin cancer or carcinoma in situ of the cervix
- •No active infection requiring oral or IV antibiotics
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Chemotherapy
- •No more than 3 prior immunotherapy regimens
- •Chemotherapy
- •No more than 3 prior chemotherapy regimens
- •Addition of radiation or a monoclonal antibody to chemotherapy is considered one treatment regimen if the addition was part of the initial treatment plan
- •Addition of these therapies due to lack of response or poor response would be considered an additional treatment regimen whether given in front-line or salvage setting
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Chemotherapy
- •No more than 3 prior radiotherapy regimens
- •No prior radioimmunotherapy
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Potential infectious complications of the addition of rituximab to autologous stem cell transplantation
- Procedure-related mortality
- Overall survival