SHS_492303 PAGJ CTGT 15251

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 evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) patients.

Inclusion Criteria:

•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.
Phase III
NCT02612311
Cancer
Hematologic
John Pagel, M.D.
TG Therapeutics, Inc.
Neil Bailey
  • Swedish Medical Center