A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Rituximab (MabThera/Rituxan) in Participants With Diffuse Large B Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL)

Sponsor
Hoffmann-La Roche
Study ID
NCT01889069
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    Rituximab will be administered at a dose of 1400 mg SC once a month for at least 4 doses during the Induction period, and at a dose of 1400 mg SC once every two months for at least 6 doses during the Maintenance period.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered as per standard local practice as a part of standard chemotherapy regimen.
  • Vincristine — DRUG
    Vincristine will be administered as per standard local practice as a part of standard chemotherapy regimen.
  • Doxorubicin — DRUG
    Doxorubicin will be administered as per standard local practice as a part of standard chemotherapy regimen.
  • Prednisone — DRUG
    Prednisone will be administered as per standard local practice as a part of standard chemotherapy regimen.
  • Bendamustine — DRUG
    Bendamustine will be administered as per standard local practice as a part of standard chemotherapy regimen.

Study Details

This single arm, multicenter study will evaluate the safety, efficacy and pharmacokinetic (PK) of subcutaneous (SC) rituximab in previously untreated participants with cluster of differentiation 20 positive (CD20+) DLBCL or FL. In addition to standard chemotherapy, participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period.

Key Dates

Start date
Jul 31, 2013
Status verified
Jul 2020
Primary completion
May 28, 2019
Completion
May 28, 2019

Study Design

Enrollment
159 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Participants will receive at least 4 doses of rituximab 1400 mg SC once a month during the Induction period, and at least 6 doses of rituximab 1400 mg SC once every two months during the Maintenance period, in addition to standard chemotherapy. Standard chemotherapy regimen included cyclophosphamide, vincristine, doxorubicin and prednisone (CHOP); or cyclophosphamide, vincristine and prednisone (CVP); or bendamustine as per standard local practice.

Primary Outcome Measure

Percentage of Participants With Administration-Associated Reactions (AAR) [ Time Frame: Baseline up to 54 months ]

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