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Clinical Trial 19150
Interventions:Bendamustine; TGR-1202; Ublituximab
Study Type: Treatment
Phase of Study: Phase II
- Julio Chavez
A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 and TGR-1202 alone in Patients A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma with Previously Treated Diffuse Large B-Cell Lymphoma
This research study will evaluate the safety and efficacy of a study drug called TGR-1202 in combination with another study drug called ublituximab with or without bendamustine and TGR-1202 alone as a possible treatment for Non-Hodgkin's Lymphoma (NHL) that has come back or that has not responded to standard treatment.
PRIMARY OBJECTIVES: To assess the efficacy of TGR-1202 alone and in combination with ublituximab in patients with previously treated DLBCL as measured by Overall Response Rate (ORR). KEY SECONDARY OBJECTIVE: To assess the efficacy of TGR-1202 alone and in combination with ublituximab in patients with previously treated DLBCL as measured by Progression-Free Survival (PFS) at Month 6. OTHER SECONDARY OBJECTIVES: To assess safety, tolerability and other efficacy outcomes. To analyze population pharmacokinetics and any other potential drug-drug interactions of ublituximab and TGR-1202. EXPLORATORY OBJECTIVES: To observe the impact of cell of origin, mutational status, and select other biomarkers on efficacy of the TGR-1202 and the ublituximab + TGR-1202 combination.