A Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)

Trial Profile

A Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 Compared to Obinutuzumab in Combination With Chlorambucil in Patients With 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) ; Umbralisib (Primary) ; Chlorambucil; Obinutuzumab
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms UNITY-CLL
  • Sponsors TG Therapeutics Inc
  • Most Recent Events

    • 16 Oct 2017 According to the TG Therapeutics Inc media release, upon completion of enrollment, this trial will evaluate Overall Response Rate (ORR) for accelerated approval.
    • 16 Oct 2017 Status changed from recruiting to active, no longer recruiting, according to a TG Therapeutics Inc media release.
    • 05 Sep 2017 According to the TG Therapeutics Inc media release, if the results comes out to be positive, the overall reponse rate data may be used to support a filing for accelerated approval.
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