Randomized Study of Rituximab (Mabthera) in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 460
- 试验地点
- 261
- 主要终点
- Time to disease progression
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. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the effects of in vivo rituximab purging and maintenance on progression-free survival in patients with relapsed or resistant follicular non-Hodgkin's lymphoma undergoing high-dose chemotherapy.
- Determine the effects of this regimen on response rate and overall survival in this patient population.
- Determine the effects of in vivo purging with rituximab on molecular remission rates in the hematopoietic product and the patients.
- Determine the safety of rituximab in the transplant setting.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to type of remission (complete vs good partial) and which remission (second vs third). Patients are randomized to one of four treatment arms.
All patients receive induction chemotherapy comprising cyclophosphamide IV over 3-4 hours on day 0 or a standard induction chemotherapy regimen. Filgrastim (G-CSF) is administered subcutaneously daily beginning on day 1.
Patients are then randomized to receive either in vivo rituximab purging or no purging following restaging after completion of induction. For those patients receiving purging (arms I and II), rituximab is administered IV once weekly for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Relapsed or resistant follicular non-Hodgkin's lymphoma (NHL)
- •No evidence of transformation to high grade or diffuse large B-cell NHL
- •CD20 positive with no evidence of transformation
- •Achievement of complete remission (CR) or very good partial remission (VGPR) following reinduction chemotherapy with any standard regimen
- •Includes patients who fail to respond to first-line chemotherapy but who achieve CR or VGPR after proceeding directly to second-line chemotherapy
- •Platelet count greater than 100,000/mm^3 after induction chemotherapy and before randomization
- •No CNS involvement
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •Bilirubin normal
- •ALT no greater than 2 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2 times ULN
- •Hepatitis B negative
- •Hepatitis C negative
- •Creatinine no greater than 2 times ULN
- •BUN no greater than 2 times ULN
- •Cardiovascular:
- •No inadequate cardiac function
- •No inadequate pulmonary function
- •Not pregnant or nursing
- •HIV negative
- •No other uncontrolled serious medical conditions
- •No other malignancy within the past 5 years except nonmelanoma skin tumors or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •More than 12 months since prior CD20 therapy, including rituximab
- •No prior peripheral blood stem cell transplantation
- •Chemotherapy:
- •See Disease Characteristics
- •No more than 3 prior chemotherapy regimens for NHL
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to greater than 30% of bone marrow
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Time to disease progression
次要结局
- Molecular remission rates
- Safety
- Response rate and survival