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
Price :
$35
*
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
- 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.