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A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination With Ibrutinib Compared to Ibrutinib Alone, in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

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Trial Profile

A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination With Ibrutinib Compared to Ibrutinib Alone, in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 May 2022

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At a glance

  • Drugs Ibrutinib (Primary) ; Ublituximab (Primary)
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms GENUINE
  • Sponsors TG Therapeutics Inc

    • Most Recent Events

    • 25 May 2021 According to a TG Therapeutics media release, results were presented at the American Society of Hematology (ASH) Annual Meeting in December 2020.
    • 25 May 2021 According to a TG Therapeutics media release, The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.
    • 25 May 2021 According to a TG Therapeutics media release, based on the data from this study, the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ublituximab, in combination with UKONIQ (umbralisib), as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2022.

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