A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Rituximab SC; Rituximab IV; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone/Prednisolone
Intervention description: First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.; Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.; Eight cycles of cyclophosphamide (750 mg/m^2 IV) administered every 3 weeks.; Eight cycles of doxorubicin (50 mg/m^2 IV) administered every 3 weeks.; Eight cycles of doxorubicin (1.4 mg/m^2 IV) administered every 3 weeks.; Eight cycles of prednisone/prednisolone (100 mg/day or 40 mg/m^2/day IV/orally) administered Days 1 to 5 of every 21 days cycle.
Intervention MeSH terms: Prednisone; Prednisolone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 410.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This two-stage, multi-center, randomized, controlled, open-label study will investigate the
      pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants
      with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized
      to receive 375 milligrams per meter square (mg/m^2) rituximab as IV infusion or 1400
      milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy.
      Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will
      receive maintenance treatment for a further maximum number of 12 cycles. Maintenance
      treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was
      designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum
      Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3
      weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1.
      Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with
      rituximab IV. The anticipated time on study treatment is 96 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cluster of differentiation 20 (CD20)-positive, follicular Non-Hodgkin's lymphoma grade
             1, 2, 3a. A tumor biopsy must have been performed within 6 months before study entry
             with material available for central review

          -  No prior treatment

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

        Exclusion Criteria:

          -  Grade 3b follicular lymphoma

          -  Transformation to high-grade lymphoma secondary to follicular lymphoma

          -  Types of Non-Hodgkin's lymphoma other than follicular lymphoma

          -  Presence or history of central nervous system (CNS) disease

          -  Corticoid therapy during the last 4 weeks, except prednisone treatment less than (<)
             20 milligrams per day (mg per day)

          -  Known active bacterial, viral, fungal, or mycobacterial, or any major episode of
             infections requiring hospitalization or treatment with IV antibiotics within 4 weeks
             of start of study medication, or oral antibiotics within 2 weeks prior to start of
             study medication