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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)

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Trial Profile

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)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 09 May 2024

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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

    • 09 May 2023 This trial has been discontinued in Poland, according to European Clinical Trials Database record.
    • 15 Apr 2022 According to a TG Therapeutics media release, the April 22, 2022, ODAC meeting will be canceled, as company decided to withdraw the pending BLA/sNDA for U2 to treat CLL/SLL.
    • 15 Apr 2022 According to a TG Therapeutics media release, the company has voluntarily withdrawn the pending Biologics License Application/supplemental New Drug Application for the combination of ublituximab and UKONIQ (umbralisib) for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma. The decision to withdraw was based on recently updated overall survival data from the UNITY-CLL Phase 3 trial that showed an increasing imbalance in OS.

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