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)

• Status: Completed
• Trial end date: 2019-05-28

Summary

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.

• Phase: Phase 3

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bendamustine Hydrochloride; Cyclophosphamide; Doxorubicin; Prednisone; Rituximab; Vincristine