a study of participant preference with subcutaneous versus intravenous mabthera/rituxan in participants with cd20+ diffuse large b-cell lymphoma or cd20+ follicular non-hodgkin's lymphoma grades 1, 2 or 3a

Conditions: Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma

Summary: this multi-center, open-label, randomized study will evaluate the participant preference with subcutaneous versus intravenous administration of mabthera/rituxan (rituximab) in participants with cd20+ diffuse large b-cell lymphoma or cd20+ follicular non-hodgkin's lymphoma. in arm a, participants will receive mabthera/rituxan 375 mg/m2 intravenously (iv) on day 1 of cycle 1 and mabthera/rituxan 1400 mg subcutaneously (sc) on day 1 of cycles 2-4, followed by mabthera/rituxan iv in cycles 5-8. participants in arm b will receive mabthera/rituxan iv in cycles 1-4 and sc in cycles 5-8. all participants will receive 6-8 cycles of standard chemotherapy (according to local country practice) with 8 cycles of mabthera/rituxan. anticipated time on study treatment is up to 24 weeks.


Eligibility criteria:
inclusion criteria: * adult participants , \>/= 18 and \</= 80 years of age * histologically confirmed, previously untreated cd20+ diffuse large b-cell lymphoma (dlbcl) or cd20+ follicular non-hodgkin's lymphoma (nhl) grade 1, 2, or 3a, according to world health organization (who) classification * an international prognostic index (ipi) score of 1-4 or ipi score of 0 with bulky disease, defined as one lesion \>/= 7.5 cm, or follicular lymphoma international prognostic index (flipi; low, intermediate or high risk) * at least one bi-dimensionally measurable lesion defined as \>/=1.5 cm in its largest dimension on ct scan * eastern cooperative oncology group (ecog) performance status \</= 3 exclusion criteria: * transformed lymphoma or follicular lymphoma iiib * primary central nervous system (cns) lymphoma, histologic evidence of transformation to burkitt lymphoma, primary mediastinal dlbcl, primary effusion lymphoma, primary cutaneous dlbcl, or primary dlbcl of the testis * history of other malignancy that could affect compliance with the protocol or interpretation of the results; this includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission for \>/= 5 years prior to enrolment; participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible * prior therapy for dlbcl or nhl, with the exception of nodal biopsy or local irradiation * prior treatment with cytotoxic drugs (with the exclusion of intrathecal methotrexate for cns prophylaxis in dlbcl) or rituximab for another condition, or prior use of an anti-cd20 drug * prior use of monoclonal antibody within 3 months prior to randomization * chemotherapy or other investigational therapy within 28 days prior to randomization * ongoing corticosteroid use \> 30 mg/day prednisolone or equivalent * inadequate renal. hematologic or hepatic function * active and/or severe infection or any major episode of infection within 4 weeks prior to randomization * active hepatitis b virus or active hepatitis c virus infection * history of human immunodeficiency (hiv) seropositive status * a positive pregnancy test in women of childbearing potential * life expectancy of less than 6 months