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

Sponsor
Hoffmann-La Roche
Study ID
NCT01649856
Phase
PHASE3
Status
Completed

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • CHOP — DRUG
    CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles
  • rituximab [MabThera/Rituxan] — DRUG
    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
  • rituximab [MabThera/Rituxan] — DRUG
    375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles

Study Details

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.

Key Dates

Start date
Aug 24, 2012
Status verified
Sep 2017
Primary completion
Oct 21, 2014
Completion
Sep 16, 2016

Study Design

Enrollment
572 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A: Rituximab SC
  • Active Comparator: B: Rituximab IV

Primary Outcome Measure

Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu) [ Time Frame: Up to approximately 4.25 years ]

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