A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma
Condition: Lymphoma, Large B-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Intervention: CHOP; rituximab [MabThera/Rituxan]; rituximab [MabThera/Rituxan]
Intervention description: CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles; The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles; 375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 572.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This multicenter, randomized, open label parallel-group study will evaluate the efficacy and
      safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with
      CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell
      lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg
      subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8
      cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study
      treatment is 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 and </= 80 years of age at time of study inclusion

          -  Histologically confirmed, previously untreated CD20-positive diffuse large B-cell
             lymphoma (DLBCL) according to the WHO classification system

          -  Patients with an International Prognostic Index (IPI) score 1-5, or IPI score 0 with
             bulky disease, defined as one lesion >/= 7.5 cm

          -  At least one bi-dimensionally measurable lesion defined as >/= 1.5 cm in its largest
             dimension on CT scan, PET-CT scan or MRI

          -  Adequate hematologic function

          -  Eastern Cooperative Oncology Group (EOCD) performance status </= 2

        Exclusion Criteria:

          -  Primary or secondary central nervous system lymphoma, histologic evidence of
             transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion
             lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis

          -  Transformed lymphoma or follicular lymphoma IIIB

          -  Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation

          -  History of other malignancy, except for curatively treated basal or squamous cell
             carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy
             that has been treated without curative intent and has been in remission without
             treatment for >/= 5 years prior to enrolment

          -  Inadequate renal or hepatic function

          -  Known human immunodeficiency virus (HIV) infection or HIV seropositive status

          -  Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. Patients
             with occult or prior HBV infection as defined by protocol may be included. Patients
             positive for HCV antibody are eligible only if polymerase chain reaction testing for
             HCV ribonucleic acid is negative.

          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
             antibodies or known sensitivity or allergy to murine products

          -  Contraindication to any of the individual components of CHOP, including prior receipt
             of anthracyclines

          -  Prior treatment with cytotoxic drugs or rituximab for another condition (e.g.
             rheumatoid arthritis) or prior use of an anti-CD20 antibody

          -  Pregnant or lactating women