Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

Phase 3 Completed 126 enrolled TG Therapeutics, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (ORR = CR \[complete response\] + PR \[partial response\]) in previously treated Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.

Timeline

Start: 2015-01-27
Primary completion: 2020-04-01
Completion: 2020-04-01

Outcome

Met primary endpoint

registry NUMBER Ublituximab + Ibrutinib: 84.4 percentage of participants NCT02301156 ↗

registry analysis (superiority test); Ublituximab + Ibrutinib vs Ibrutinib; p = 0.0463; Cochran-Mantel-Haenszel NCT02301156 ↗

paper the overall response rate was 53 (83%) of 64 patients in the ublituximab plus ibrutinib group and 40 (65%) of 62 PMID 33631112 ↗

Publications

Sharman JP, Brander DM, Mato AR, Ghosh N, Schuster SJ, Kambhampati S, Burke JM, Lansigan F, Schreeder MT, Lunin SD, Zweibach A, Shtivelband M, Travis PM, Chandler JC, Kolibaba KS, Sportelli P, Miskin HP, Weiss MS, Flinn IW. Ublituximab plus ibrutinib versus ibrutinib alone for patients with relapsed or refractory high-risk chronic lymphocytic leukaemia (GENUINE): a phase 3, multicentre, open-label, randomised trial. Lancet Haematol. 2021 Apr;8(4):e254-e266. doi: 10.1016/S2352-3026(20)30433-6. Epub 2021 Feb 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibrutinib	Small molecule	420 mg	Oral
Subject	Ublituximab	Monoclonal antibody	900 mg	Intravenous