A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Intervention: Rituximab; Cyclophosphamide; Vincristine; Doxorubicin; Prednisone; Bendamustine
Intervention description: Rituximab will be administered at a dose of 1400 mg SC once a month for at least 4 doses during the Induction period, and at a dose of 1400 mg SC once every two months for at least 6 doses during the Maintenance period.; Cyclophosphamide will be administered as per standard local practice as a part of standard chemotherapy regimen.; Vincristine will be administered as per standard local practice as a part of standard chemotherapy regimen.; Doxorubicin will be administered as per standard local practice as a part of standard chemotherapy regimen.; Prednisone will be administered as per standard local practice as a part of standard chemotherapy regimen.; Bendamustine will be administered as per standard local practice as a part of standard chemotherapy regimen.
Intervention MeSH terms: Prednisone; Cyclophosphamide; Bendamustine Hydrochloride; Rituximab; Doxorubicin; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic
      (PK) of subcutaneous (SC) rituximab in previously untreated participants with cluster of
      differentiation 20 positive (CD20+) DLBCL or FL. In addition to standard chemotherapy,
      participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the
      Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during
      the Maintenance period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, CD20+ DLBCL or CD20+ follicular non-Hodgkin's lymphoma (NHL)
             Grade 1, 2 or 3a, according to the World Health Organization (WHO) classification
             system

          -  Currently being treated with rituximab intravenously (IV) in the Induction or
             Maintenance period, having received at least one full dose of rituximab IV, defined as
             standard full dose of rituximab IV 375 milligrams per square-meter (mg/m^2)
             administered without interruption or early discontinuation (i.e. tolerability issues)

          -  Expectation and current ability for the participant to receive at least 4 additional
             cycles of treatment during the Induction period or 6 additional cycles of treatment
             during the Maintenance period (participants with follicular NHL)

          -  An International Prognostic Index (IPI) score of 1-4 or IPI score of 0 with bulky
             disease, defined as one lesion greater than or equal to (>=) 7.5 centimeters (cm), or
             Follicular Lymphoma International Prognostic Index (FLIPI) (low, intermediate or high
             risk) assessed before the first rituximab IV administration in Induction period

          -  At least one bi-dimensionally measurable lesion defined as >=1.5 cm in its largest
             dimension on computed tomography (CT) scan

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
             (<=) 3

        Exclusion Criteria:

          -  Transformed lymphoma or FL IIIB

          -  Primary central nervous system lymphoma, histologic evidence of transformation to a
             Burkitt lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the
             testis, or primary cutaneous DLBCL

          -  History of other malignancy

          -  Ongoing corticosteroid use greater than (>) 30 milligrams per day (mg/day) of
             prednisone or equivalent

          -  Inadequate renal, hematologic, or hepatic function

          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
             antibodies or known sensitivity or allergy to murine products

          -  Contraindications to any of the individual components of standard chemotherapy

          -  Other serious underlying medical conditions, which, in the Investigator's judgement,
             could impair the ability of the participant to participate in the study

          -  Recent major surgery (within 4 weeks prior to dosing, other than for diagnosis)

          -  Active hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, or human
             immunodeficiency virus (HIV) infection