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Clinical Trial 19151
Cancer Type: Malignant Hematology
Interventions:Chlorambucil; Obinutuzumab; TGR-1202; Ublituximab
Study Type: Treatment
Phase of Study: Phase III
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)
This study is being done to see how effective two investigational drugs; ublituximab (also referred to as TG-1101) and TGR-1202 are when they are given in combination compared to two FDA approved drugs; obinutuzumab (also referred to as Gazyva®) and chlorambucil to patients with Chronic Lymphocytic Leukemia (CLL). This study is also being done to see if the combination of the two investigational drugs ublituximab and TGR-1202 are more effective when given together versus if ublituximab is given alone or if TGR-1202 is given alone.
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. KEY 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. OTHER SECONDARY OBJECTIVES: To assess safety, tolerability and other efficacy outcomes. To determine the pharmacokinetics and any potential drug-drug.