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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Feb 2018

At a glance

  • Drugs Rituximab (Primary) ; Rituximab (Primary) ; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine
  • Indications Follicular lymphoma
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms SABRINA
  • Sponsors Roche
  • Most Recent Events

    • 29 Nov 2017 This trial has been completed in Spain.
    • 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.
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