A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Chemotherapy (Induction Period); Rituximab
Intervention description: Participants will receive standard combination chemotherapy every 3-4 weeks for 6 to 8 months. The chemotherapy regimen will be selected at Investigator's discretion, for individual participant. Study protocol does not enforce any particular chemotherapy regimen.; Participants will receive rituximab according to the regimen specified in individual arm.
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 692.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and
      safety of subcutaneously administered rituximab in comparison with observation only as
      maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's
      lymphoma (NHL). All participants will receive induction therapy with rituximab (375
      milligrams per square meter [mg/m^2] intravenously [IV] in Cycle 1, then 1400 mg subcutaneous
      [SC] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of
      maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing
      therapy and showing partial or complete response will be randomized to receive either
      rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II
      period and will be followed for at least 15 months. Anticipated time on study treatment is
      until disease progression, unacceptable toxicity or end of study, whichever occurs first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed Cluster of Differentiation 20-positive (CD20+) follicular NHL
             Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström's macroglobulinemia or
             lymphoplasmacytic lymphoma, marginal zone lymphoma) according to World Health
             Organization (WHO) classification system

          -  Participants must have received and must have relapsed or been refractory to, one or
             more lines of adequate therapy prior to enrollment, including at least one line
             consisting of immunotherapy and/or chemotherapy and/or radiotherapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
             (<=) 2

        Exclusion Criteria:

          -  Transformation to high-grade lymphoma

          -  Aggressive lymphoma (for example, mantle cell lymphoma [MCL])

          -  Presence or history of central nervous system (CNS) lymphomatous disease

          -  Other malignancy within 5 years prior to enrollment, except for curatively treated
             carcinoma in situ of the cervix, squamous cell carcinoma of the skin or basal cell
             skin cancer, or cervical carcinoma Stage 1B or less, breast cancer in situ or
             localized prostate cancer Stage T1c if treated with curative intent and relapse- and
             metastasis-free for at least 2 years prior to enrollment

          -  Inadequate hematological, hepatic or renal function

          -  Known human immunodeficiency virus (HIV) infection

          -  Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic
             infections, active hepatitis B or C)

          -  Pregnant or breastfeeding women