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)

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)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2017

At a glance

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

    • 16 Oct 2017 According to a TG Therapeutics media release, the Company and the FDA discussed the potential use of PFS results from this trial to support the full approval of TG-1101. The Company plans to have a follow-up meeting with the FDA to discuss the use of the PFS endpoint in more detail before the end of the year and also plans to monitor the regulatory landscape for new approvals of agents for previously treated high-risk CLL while continuing to make preparations for a BLA filing as early as 2018.
    • 16 Oct 2017 According to a company media release, TG Therapeutics met with the US FDA regarding the use of the results from this trial to support a BLA filing for approval of ublituximab in combination with ibrutinib. The FDA confirmed that accelerated approval based on ORR would be a review issue. The FDA encouraged the Company to consider future available therapy in its risk/benefit analysis as part of any potential future BLA filing that may impact accelerated approval.
    • 16 Jun 2017 According to a TG Therapeutics Inc media release, data from the study presented at the 14th International Conference on Malignant Lymphoma (ICML)
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