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A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma

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Trial Profile

A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 19 Sep 2023

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At a glance

  • Drugs Ublituximab (Primary) ; Umbralisib (Primary) ; Bendamustine
  • Indications Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Non-Hodgkin's lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms UNITY; UNITY-iNHL; UNITY-NHL
  • Sponsors TG Therapeutics Inc

Most Recent Events

  • 08 Oct 2022 This trial has been discontinued in Poland, according to European Clinical Trials Database record.
  • 20 Jul 2022 Status changed from active, no longer recruiting to discontinued.
  • 04 Feb 2022 According to media release, the U.S. Food and Drug Administration (FDA) is investigating a possible increased risk of death associated with umbralisib (Ukoniq), a kinase inhibitor including PI3K-delta and CK1-epsilon, approved to treat marginal zone and follicular lymphomas, determined that initial findings from this trial. The FDA is continuing to evaluate the results of this trial and may also hold a future public meeting to discuss these findings and explore the continued marketing of Ukoniq.

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