Clinical Trial 19150

Cancer Type: Malignant Hematology
Interventions:Bendamustine; TGR-1202; Ublituximab

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Julio Chavez

Overview

Study Title

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 Lymphomawith Previously Treated Diffuse Large B-Cell Lymphoma

Summary

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.

Objective

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.

Inclusion Criteria

  • Diagnosis of Non-Hodgkin's Lymphoma including Diffuse Large B-cell Lymphoma, Follicular, Small Lymphocytic and Marginal Zone Lymphoma
  • Relapsed or refractory to prior standard therapy and patients who are not candidates for high-dose therapy or autologous stem cell transplant
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

  • Exclusion Criteria

  • Any major surgery, chemotherapy or immunotherapy within the last 21 days
  • Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
  • Autologous hematologic stem cell transplant within 6 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
  • Prior therapy with a PI3K delta inhibitor