A Randomized, Open-label, Mutli-centre Study to Evaluate Patient Preference With Subcutaneous Administration of Rituximab Versus Intravenous Rituximab in Previously Untreated Patients With CD20+ Diffuse Large B-cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2, OR 3A 3a

Trial Profile

A Randomized, Open-label, Mutli-centre Study to Evaluate Patient Preference With Subcutaneous Administration of Rituximab Versus Intravenous Rituximab in Previously Untreated Patients With CD20+ Diffuse Large B-cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2, OR 3A 3a

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jun 2017

At a glance

  • Drugs Rituximab (Primary) ; Rituximab (Primary) ; Bendamustine; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine
  • Indications Diffuse large B cell lymphoma; Follicular lymphoma; Non-Hodgkin's lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms PrefMab
  • 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).
    • 10 Jun 2017 Biomarkers information updated
    • 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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