A Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination with TGR-1202 (Umbralisib) 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 (Umbralisib) 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: 14 Nov 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

    • 18 Oct 2017 Planned number of patients changed from 450 to 600.
    • 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.
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