A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 29 Jun 2017
At a glance
- Drugs Rituximab (Primary) ; Rituximab (Primary) ; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine
- Indications Follicular lymphoma
- Focus Pharmacokinetics; Registrational; Therapeutic Use
- Acronyms SABRINA
- Sponsors Roche
- 22 Jun 2017 Based on the data from NCT01200758, NCT01292603, NCT01649856 and NCT01724021 studies, U.S. FDA approved RITUXAN HYCELA for subcutaneous injection for the treatment of adults with the following blood cancers: previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), and previously untreated and previously chronic lymphocytic leukemia (CLL).
- 29 Mar 2017 According to a Halozyme Therapeutics media release, an Oncologic Drug Advisory Committee of the U.S. Food and Drug Administration has provided unanimous recommendation for subcutaneous rituximab coformulated with Halozyme Enhanze Technology. The FDA action date is June 26, 2017. Data from this study supported the application.
- 13 Dec 2016 According to a Roche media release, health canada has approved the subcutaneous formulation of RITUXAN (rituximab) in combination with chemotherapy agents for the treatment of patients with low-grade CD20 antigen positive B-cell non-Hodgkin's lymphoma.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History