Rituximab With or Without Lenalidomide in Treating Patients With Previously Untreated Follicular Lymphoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed follicular lymphoma
• •* Stage III or IV disease OR stage II disease not suitable for radiotherapy
• •* Grades 1, 2, or 3a disease
• •Previously untreated disease
• •CD20-positive disease
• •Patients in need of systemic therapy, meeting at least 1 of the following criteria:
• •* Symptomatic enlarged lymph nodes, spleen, or other lymphoma manifestations
• •* Bulky disease ≥ 6 cm in long diameter
• •* Clinically significant progression over at least 6 months of any tumor lesion
• •* Anemia (hemoglobin \< 100 g/L) or thrombocytopenia (platelet count \< 100 x 10\^9/L) due to lymphoma
• •* Clinically significant progressive decrease in hemoglobin or platelet count due to lymphoma
• •* B-symptoms, weight loss \> 10% within the past 6 months, drenching night sweats, or fever \> 38°C not due to infection
• •At least one two-dimensionally measurable lesion with longest transverse diameter \> 10 mm
• •Paraffin-embedded tumor tissue available
• •No known CNS involvement
• •PATIENT CHARACTERISTICS:
• •WHO performance status 0-2
• •EF ≥ 50% for patients with a history of cardiac disease or older than 70 years
• •Neutrophil count ≥ 1.5 x 10\^9/L
• •Platelet count ≥ 100 x 10\^9/L
• •Bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless due to Gilbert syndrome)
• •ALT ≤ 2.5 x ULN
• •Alkaline phosphatase ≤ 2.5 x ULN
• •Creatinine clearance ≥ 30 mL/min
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception 4 weeks prior to, during, and for 12 months after completion of study therapy
• •Must be compliant and geographically proximal to allow for proper staging and follow-up
• •No serious underlying medical condition, at the judgment of the investigator, which could impair the ability of the patient to participate in the trial (e.g., active autoimmune disease or uncontrolled diabetes)
• •No malignancy within the past 3 years except for adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer
• •No psychiatric disorder precluding understanding information of trial-related topics, giving informed consent, or interfering with compliance for oral drug intake
• •No known hypersensitivity to trial drugs or hypersensitivity to any other components of the trial drugs
• •No known HIV positivity or hepatitis C infection
• •No serological evidence of current or past hepatitis B infection, unless the serological findings are clearly due to vaccination
• •PRIOR CONCURRENT THERAPY:
• •No prior systemic therapy for this disease
• •At least 3 months since prior radiotherapy
• •At least 30 days since prior treatment in another clinical trial
• •At least 4 weeks since prior and no concurrent corticosteroids unless administered as prophylaxis in at-risk patients for ≤ 3 days or at a dose equivalent to prednisone ≤ 15 mg/day, for indications other than lymphoma or lymphoma-related symptoms
• •No concomitant drugs contraindicated for use with the trial drugs
• •No other concurrent experimental drugs or anticancer therapy
• •No other concurrent investigational treatments