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
Condition: Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular
Intervention: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP); Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP); Bendamustine; Rituximab; Rituximab; Rituximab; Rituximab
Intervention description: Standard chemotherapy; Standard chemotherapy; Standard chemotherapy; 1400 mg subcutaneously (SC), Day 1 Cycles 2-4; 375 mg/m2 IV, Day 1 Cycles 1-4; 375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8; 1400 mg SC, Day 1 Cycles 5-8
Intervention MeSH terms: Prednisone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Cyclophosphamide; Bendamustine Hydrochloride; Rituximab; Vincristine; Doxorubicin; Liposomal doxorubicin; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 743.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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