MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma
Condition: Lymphoma, Non Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Rituximab
Intervention description: 1400 mg will be injected subcutaneously (SC).
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This open-label, single-arm, phase IIIb study will evaluate the safety of switching from
      intravenous (IV) to subcutaneous (SC) administration of rituximab during first-line treatment
      for participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell
      lymphoma (DLBCL) who have already received at least one full dose of rituximab IV.
      Participants with FL will be given 1400 mg rituximab SC during induction therapy (once
      monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400
      mg SC of rituximab will be given to participants with DLBCL once monthly for 4-7 cycles.
      Treatment duration is expected to last up to 7 months for participants with DLBCL and up to
      32 months for participants with FL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 and ≤ 80 years at time of enrolment.

          -  Life expectancy ≥ 6 months.

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.

          -  Fertile men or women of childbearing potential must use effective contraception until
             at least 12 months after the last dose; women must not be pregnant.

          -  Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+
             follicular Non-Hodgkin Lymphoma (FL) grade 1, 2 or 3a according to the World Health
             Organisation Classification system.

        Induction only:

          -  Participants with Follicular Lymphoma should meet Groupe D'Etude des Lymphomes
             Folliculaires (GELF) criteria to initiate treatment.

          -  At least tumor >/= 1.5 cm as measured by computed tomography (CT) scan.

        FL treatment-related criteria

        - Currently being treated with rituximab IV during first-line therapy and has received at
        least one full dose of rituximab IV.

        Exclusion Criteria:

          -  Transformed lymphoma.

          -  Primary central nervous system lymphoma, primary effusion lymphoma, primary
             mediastinal DLBCL, DLBCL of the testis, primary cutaneous DLBCL or histologic evidence
             of transformation to a Burkitt lymphoma.

          -  History of other cancer, including one that has been treated but not with curative
             intent, unless the cancer has been in remission without treatment for >/= 5 years
             prior to dosing. Note: Participants with a history of cured skin cancer or in situ
             carcinoma of the cervix are eligible for the study.

          -  Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent. Note: Participants
             receiving corticosteroid treatment with </= 30 mg/day of prednisone or equivalent must
             be on a stable regimen for at least 4 weeks prior to start of dosing.

          -  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.

          -  For participants with DLBCL: Contraindication to any of the individual components of
             CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), including prior
             anthracycline treatment.

          -  For participants with FL: contraindication to standard chemotherapy.

          -  Other serious underlying medical conditions.

          -  Recent major surgery (within 4 weeks prior to dosing), other than for diagnosis.

          -  Active and/or severe infections (excluding nail fungal infections) or any infection
             requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to
             dosing.

          -  Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. Note:
             Participants testing positive for Hepatitis B or C virus antibodies but with an
             undetectable viral load may be included.

          -  History of Human Immunodeficiency Virus (HIV) positive status.