Phase II Trial of Rituximab and Autologous Stem Cell Transplantation for Refractory B Cell Large Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 2-year event free survival
研究概览
简要总结
RATIONALE: Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as rituximab, and chemotherapy, such as cyclophosphamide, helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for peripheral stem cell transplant. Giving chemotherapy, such as carmustine, etoposide, and cyclophosphamide, before transplant stops the growth of cancer cells by stopping them from dividing or killing them. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. More rituximab is given after transplant to kill any remaining cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with cyclophosphamide and G-CSF followed by combination chemotherapy works in treating patients undergoing an autologous stem cell transplant followed by rituximab and GM-CSF for refractory diffuse large B-cell lymphoma.
详细描述
OBJECTIVES:
- Determine the disease-free and overall survival of patients with refractory diffuse large B-cell lymphoma treated with stem cell mobilization comprising rituximab, cyclophosphamide, and filgrastim (G-CSF) followed by high-dose chemotherapy comprising carmustine, etoposide, and cyclophosphamide and autologous peripheral blood stem cell transplantation, rituximab, and sargramostim (GM-CSF).
- Determine any potential infectious complications in patients treated with this regimen.
- Determine the effect of GM-CSF on antibody-dependent cellular cytotoxicity in patients treated with this regimen.
OUTLINE: Stem cell mobilization: Patients receive rituximab IV over 4-8 hours on days 1, 5, 8, and 13. Patients also receive cyclophosphamide IV over 1-2 hours on day 9 and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 10 and continuing until an adequate number of peripheral blood stem cells (PBSC) are collected.
High-dose preparative regimen: Patients receive carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on day -2.
Autologous PBSC transplantation: Patients undergo autologous PBSC transplantation on day 0. Patients receive sargramostim (GM-CSF) SC once daily beginning on day 6 and continuing until blood counts recover.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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 B-cell lymphoma, meeting 1 of the following criteria:
- •Failed to achieve at least partial remission
- •Failed to respond to prior primary therapy or salvage chemotherapy
- •Disease progression within 6 weeks after achieving remission
- •CD20 expression at diagnosis or relapse
- •No more than 4 prior regimens using chemotherapy, radiotherapy, or immunotherapy
- •The addition of radiotherapy or a monoclonal antibody to chemotherapy is considered 1 treatment regimen provided the addition was part of the initial treatment plan
- •The addition of these therapies due to lack of response or poor response is considered an additional treatment regimen whether given in the front line or salvage setting
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Direct bilirubin ≤ 2 mg/dL
- •AST or ALT < 3 times upper limit of normal
- •Creatinine ≤ 2.0 mg/dL
- •Cardiovascular
- •Ejection fraction ≥ 40%
- •DLCO ≥ 60% of predicted
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No active infection requiring oral or IV antibiotics
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •See Radiotherapy
- •Chemotherapy
- •See Disease Characteristics
- •Radiotherapy
- •See Disease Characteristics
- •No prior radioimmunotherapy
排除标准
- 未提供
结局指标
主要结局
2-year event free survival
次要结局
- Overall survival