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A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)

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Trial Profile

A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Apr 2022

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At a glance

  • Drugs Rituximab (Primary) ; Rituximab (Primary) ; Cyclophosphamide; Doxorubicin; Prednisolone; Prednisone; Vincristine
  • Indications Diffuse large B cell lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms MABEASE
  • Sponsors Roche

    • Most Recent Events

    • 25 Jun 2017 Results presented at the 22nd Congress of the European Haematology Association
    • 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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