Rituximab in Treating Patients With Follicular Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed follicular lymphoma Grade 1, 2, 3a, or 3b disease by WHO staging system CD20-positive by immunohistochemistry Previously untreated disease OR meets 1 of the following criteria for response to prior treatment: Chemotherapy-resistant disease Relapsed or progressive disease Stable disease At least 12 weeks since prior systemic treatment At least 1 bidimensionally measurable lesion ≥ 11 mm by CT scan or MRI No transformation to high-grade lymphoma secondary to low-grade follicular lymphoma No prior or current CNS disease (i.e., CNS lymphoma or lymphomatous meningosis) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular Ejection fraction ≥ 50% by echocardiography or MUGA Immunologic No acute or ongoing infection No HIV infection No active autoimmune disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after completion of the study treatment No uncontrolled diabetes mellitus No other medical condition that would preclude study participation No other malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix No other condition (e.g., geographic proximity) that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy See Radiotherapy Prior rituximab allowed Chemotherapy See Disease Characteristics Endocrine therapy More than 4 weeks since prior regular administration of corticosteroids Dose equivalent to ≤ 20 mg/day prednisone allowed for conditions other than lymphoma or lymphoma-related symptoms No concurrent corticosteroids for prevention or treatment of side effects except acute life-threatening side effects Radiotherapy Prior radiolabeled anti-CD20 therapy (administered alone or in combination with cytostatic drugs) allowed provided patient has achieved partial or complete response after the therapy At least 12 months since prior anti-CD20 therapy Surgery Not specified Other More than 30 days since prior systemic tumor therapy More than 30 days since prior participation in another clinical trial No other concurrent anticancer therapy
Sites / Locations
- Clinical Center - Institute of Hematology
- Istituto Europeo di Oncologia IEO
- Clinical Center Skopje
- Clinical Center of Serbia
- NOU - National Institute for Oncology
- Panorama Medical Centre
- Sandton Oncology Centre
- Kantonspital Aarau
- Kantonsspital Baden
- St. Claraspital AG
- Universitaetsspital Basel
- Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
- Inselspital Bern
- Breitenbach Praxis Dr. Haberthür
- Kantonsspital Bruderholz
- Kantonsspital Graubuenden
- Hopital Cantonal Universitaire de Geneve
- Centre Hospitalier Universitaire Vaudois
- Kantonsspital
- Istituto Oncologico della Svizzera Italiana
- Hôpital Pourtalès
- Kantonsspital - St. Gallen
- SpitalSTS AG Simmental-Thun-Saanenland
- City Hospital Triemli
- Klinik Hirslanden
- UniversitaetsSpital Zuerich
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Arm A: Rituximab every 2 months x4
Arm B: Rituximab (5 years)
Rituximab 375 mg/m2 every 2 months x4
Rituximab 375 mg/m2 every 2 months for 5 years or until PD, relapse or unacceptable toxicity