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Sponsor: Hoffmann-La Roche
Conditions: Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
Interventions: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP), Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP), Bendamustine, Rituximab, Rituximab
Countries: Argentina, Australia, Austria, Brazil, Canada, Chile, Colombia, Croatia
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.
Sex: ALL
Age: 18 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Buenos Aires, Argentina
- Corrientes, Argentina
- Santa Fe, Argentina
- Canberra, Australian Capital Territory, Australia
- Camperdown, New South Wales, Australia
- Liverpool, New South Wales, Australia
- Randwick, New South Wales, Australia
- Brisbane, Queensland, Australia
- Adelaide, South Australia, Australia
- Hobart, Tasmania, Australia
- Geelong, Victoria, Australia
- Malvern, Victoria, Australia
- Melbourne, Victoria, Australia
- Wodonga, Victoria, Australia
- Nedlands, Western Australia, Australia
- Perth, Western Australia, Australia
- Krems, Austria
- Linz, Austria
- Salzburg, Austria
- Steyr, Austria
- Vienna, Austria
- Belo Horizonte, Minas Gerais, Brazil
- Juiz de Fora, Minas Gerais, Brazil
- Varginha, Minas Gerais, Brazil
- Curitiba, Paraná, Brazil
- Londrina, Paraná, Brazil
- Recife, Pernambuco, Brazil
- Caxias do Sul, Rio Grande do Sul, Brazil
- Novo Hamburgo, Rio Grande do Sul, Brazil
- Santa Maria, Rio Grande do Sul, Brazil
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