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)
Jan A. Burger
The goal of this clinical research study is to learn more about the safety and effects of different study drugs when given to patients with chronic lymphocytic leukemia (CLL). In this study, the standard drug combination of obinutuzumab and chlorambucil will be compared to the study drugs TGR-1202 and ublituximab. The study drugs will be given both alone and in combination with each other.
Treatment Location: N/A
Primary Objectives To establish that the combination of ublituximab + TGR-1202 is superior to the combination of obinutuzumab + chlorambucil as measured by Progression-Free Survival (PFS) in patients with CLL Secondary Objectives To establish that the combination of ublituximab + TGR-1202 provides clinical benefit over both ublituximab alone and TGR-1202 alone To evaluate and compare the combination of ublituximab + TGR-1202 to the combination of obinutuzumab + chlorambucil with respect to overall response rate in patients with CLL To assess safety, tolerability and other efficacy outcomes. To determine the pharmacokinetics and any potential drug-drug interactions of ublituximab and TGR-1202 in combination.
IRB Review and Approval Date: 09/08/2016
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Jan A. Burger
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