A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma
Phase of Trial: Phase II/III
Latest Information Update: 10 Aug 2017
At a glance
- Drugs Bendamustine (Primary) ; Ublituximab (Primary) ; Umbralisib (Primary)
- Indications Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; MALT lymphoma; Non-Hodgkin's lymphoma
- Focus Registrational; Therapeutic Use
- Acronyms UNITY-NHL
- Sponsors TG Therapeutics Inc
- 10 Aug 2017 According to a TG Therapeutics media release, based on pre-specified efficacy thresholds of ORR, the DSMB recommended the Company cease enrollment into the single agent TGR-1202 arm, while continuing enrollment into the TG-1101 + TGR-1202 arm which has demonstrated an acceptable level of efficacy to warrant continued evaluation.
- 28 Jun 2017 Planned number of patients changed from 200 to 500.
- 28 Jun 2017 This study now includes patients with Diffuse Large B-cell Lymphoma along with Non-Hodgkin's Lymphoma, Follicular, Small Lymphocytic and Marginal Zone Lymphoma. Thus accordingly changes in scientific title with acronym, inclusion-exclusion criteria and indications. Patients are now receiving treatment of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone. Thus accordingly changes in purpose, treatment arms, patient no etc.