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: 08 Dec 2017
At a glance
- Drugs Ublituximab (Primary) ; Umbralisib (Primary) ; Bendamustine
- Indications Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Marginal-zone-B-cell-lymphoma; Non-Hodgkin's lymphoma
- Focus Registrational; Therapeutic Use
- Acronyms UNITY-NHL
- Sponsors TG Therapeutics Inc
- 08 Dec 2017 According to a TG Therapeutics Inc media release, an integrated safety analysis from 5 phase I or II sudies, will be presented at the upcoming 59th American Society of Hematology (ASH) annual meeting.
- 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.