A Phase 3 - Ublituximab in Combination with TGR-1202
Research type
Research Study
Full title
A Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination with TGR-1202 Compared to Obinutuzumab in Combination with Chlorambucil in Patients with Chronic Lymphocytic Leukemia (CLL)
IRAS ID
209789
Contact name
John Gribben
Contact email
Sponsor organisation
TG Therapeutics, Inc.
Eudract number
2015-005758-36
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
The purpose of this phase III, randomised study, four-arm trial is to demonstrate the superiority of ublituximab in combination with TGR-1202 in the treatment of patients with chronic lymphocytic leukemia (CLL) in terms of improved progression-free survival (PFS) compared to treatment with obinutuzumab in combination with chlorambucil. The combination of ublituximab and TGR-1202 will also be compared to ublituximab alone and TGR-1202 alone to demonstrate the contribution of each agent in the combination regimen. Participants will be randomized in a 1:1:1:1 ratio to one of four treatment arms: ublituximab in combination with TGR-1202 (Arm A), obinutuzumab in combination with chlorambucil (Arm B), ublituximab alone (Arm C), or TGR-1202 alone (Arm D). Approximately 175 patients will be enrolled in total into each of Arms A and B for the PFS analysis, and up to 175 patients may be enrolled into each of Arms C and D. During the study, patients from Treatment Arms B, C, and D with disease progression, and non-progressed patients at the end of the study may be enrolled into an open Companion Study with treatment with the ublituximab and TGR-1202 combination, until they show disease progression, are unable to continue treatment for any reason such as lack of tolerability, or until the treatment is commercially available. The total estimated duration of the study is at 4 years, including 2 years to accrue patients, with 2 years for treatment and follow-up.
REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/1810
Date of REC Opinion
25 Nov 2016
REC opinion
Further Information Favourable Opinion