A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination With Ibrutinib Compared to Ibrutinib Alone, in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 20 Nov 2017
At a glance
- Drugs Ublituximab (Primary) ; Ibrutinib
- Indications Chronic lymphocytic leukaemia
- Focus Registrational; Therapeutic Use
- Acronyms GENUINE
- Sponsors TG Therapeutics Inc
- 11 Nov 2017 Planned End Date changed from 1 Dec 2017 to 1 Aug 2018.
- 11 Nov 2017 Planned primary completion date changed from 1 Oct 2017 to 1 Jun 2018.
- 16 Oct 2017 According to a TG Therapeutics media release, the Company and the FDA discussed the potential use of PFS results from this trial to support the full approval of TG-1101. The Company plans to have a follow-up meeting with the FDA to discuss the use of the PFS endpoint in more detail before the end of the year and also plans to monitor the regulatory landscape for new approvals of agents for previously treated high-risk CLL while continuing to make preparations for a BLA filing as early as 2018.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History