Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)

Standard chemotherapy

drug

Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)

Standard chemotherapy

drug

Bendamustine

Standard chemotherapy

drug

Rituximab

1400 mg subcutaneously (SC), Day 1 Cycles 2-4

drug

Rituximab

375 mg/m2 IV, Day 1 Cycles 1-4

drug

Rituximab

375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8

drug

Rituximab

1400 mg SC, Day 1 Cycles 5-8

A Randomized, Open-label, Mutli-centre Study to Evaluate Patient Preference With Subcutaneous Administration of Rituximab Versus Intravenous Rituximab in Previously Untreated Patients With CD20+ Diffuse Large B-cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2, OR 3A

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)

Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)

Bendamustine

Rituximab

Rituximab

Rituximab

Rituximab

Ubicaciones

Patrocinadores