An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy in Patients With Advanced Stage, Asymptomatic, Non-Bulky Follicular Lymphoma

CDR0000427312

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.

2004-09-01

2014-03-01

2023-09-14

Completed

Early phase I

462

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: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 10 g/dL Hepatic * AST and ALT normal * Alkaline phosphatase normal * Bilirubin normal Renal * Creatinine \< 2 times upper limit of normal (unless due to lymphoma) Other * 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 Surgery * Not specified Other * No prior therapy for lymphoma

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 462, 'type': 'ACTUAL'}}

2024-05-09