Clinical Trial 19151

Cancer Type: Malignant Hematology
Interventions:Chlorambucil; Obinutuzumab; TGR-1202; Ublituximab

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Javier Pinilla-Ibarz

Overview

Study Title

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)

Summary

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.

Objective

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.

Inclusion Criteria

  • 18 years of age and older
  • Treatment naïve or previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
  • 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 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded.
  • Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
  • Prior therapy with obinutuzumab and/or chlorambucil or a PI3K delta inhibitor