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

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
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top