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)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Jun 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

    • 23 May 2017 Enrollment completion is expected by the end of 2017, according to a TG Therapeutics media release.
    • 23 May 2017 According to a TG Therapeutics media release, the DSMB reviewed safety data from all patients on study (n>270) as of the data cut-off date, including patients with both treatment naive and relapsed/refractory CLL, and again identified no safety concerns in any treatment group (treatment naive or previously treated) and recommended the continuation of the study without modification. Pivotal overall response rate data from this trial are expected in the third quarter of 2018.
    • 23 May 2017 According to a TG Therapeutics media release, based on the ORR data available, and in accordance with the statistical analysis plan in the study's SPA, the DSMB determined that contribution has been established and recommended that the Company cease enrollment into the single agent arms. The study will now continue enrollment in a 1:1 ratio to only the two combination arms: the investigational arm of ublituximab plus TGR-1202 and the control arm of obinutuzumab plus chlorambucil.
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