An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy in Patients With Advanced Stage, Asymptomatic, Non-Bulky Follicular Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 462
- 试验地点
- 72
- 主要终点
- Time until initiation of therapy (chemotherapy or radiotherapy)
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. It is not yet known whether rituximab is more effective than observation in treating non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying rituximab to see how well it works compared to observation in treating patients with newly diagnosed stage II, stage III, or stage IV follicular non-Hodgkin's lymphoma with no symptoms.
详细描述
OBJECTIVES:
Primary
- Compare time to initiation of systemic chemotherapy or radiotherapy in patients with newly diagnosed, previously untreated, asymptomatic stage II-IV non-bulky follicular non-Hodgkin's lymphoma treated with rituximab vs observation only.
Secondary
- Compare the frequency of clinical spontaneous remission in patients treated with these regimens.
- Compare overall and cause-specific survival of patients treated with these regimens.
- Determine the effect of rituximab on complete and partial response in patients treated with subsequent systemic chemotherapy.
- Compare quality of life, in terms of functional well-being and anxiety and depression, of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed follicular non-Hodgkin's lymphoma
- •Diagnosed within the past 3 months
- •Grade 1, 2, or 3a disease
- •Stage II-IV disease
- •No evidence of histological transformation
- •Bidimensionally measurable disease by clinical examination or radiography
- •Asymptomatic disease without B symptoms or severe pruritus
- •Low tumor burden, defined by all of the following criteria:
- •Lactic dehydrogenase normal
- •Largest nodal or extranodal mass < 7 cm
- •No more than 3 nodal sites with a diameter > 3 cm
- •No clinically detectable significant serous effusion by chest x-ray
- •Clinically non-evident small effusion on CT scan is not considered significant
- •Spleen enlargement ≤ 16 cm by CT scan
- •Circulating tumor cells < 5,000/mm^3
- •No organ compression (i.e., ureteric obstruction)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin > 10 g/dL
- •AST and ALT normal
- •Alkaline phosphatase normal
- •Bilirubin normal
- •Creatinine < 2 times upper limit of normal (unless due to lymphoma)
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 12 months after completion of rituximab
- •No known HIV positivity
- •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 critical organ failure
- •No other immediate life-threatening disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •No prior therapy for lymphoma
排除标准
- 未提供
研究组 & 干预措施
Arm C Rituximab 4 and Rixuximab Maintenance
4 infusions - 375mg/m2 every 2 months. A single dose of rituximab (375mg/m2 will then be given at 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92 and 100 weeks
干预措施: rituximab (Biological)
Watch and Wait
Watch and Wait - no treatment
干预措施: No treatment (Other)
结局指标
主要结局
Time until initiation of therapy (chemotherapy or radiotherapy)
时间窗: Time from randomisation until the first day systemic chemotherapy or radiotherapy is given. If rituximab is given to patients in the watch and wait arm this will be considered as initiation of chemotherapy.
次要结局
- Overall survival(Time from randomisation to death from any cause.)
- Cause specific survival(Time from randomisation to death from lymphoma or immediate therapy related toxicity)
- Frequency of clinical spontaneous remission(From randomisation until the initiation of chemotherapy in the watch and wait arm)
- Response rate at 25 months(Response at 25 months)