SHS_492269 PAGJ CTGT 15050

A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination with Ibrutinib Compared to Ibrutinib Alone, in Patients with Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

This study evaluates the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone in previously treated Chronic Lymphocytic Leukemia (CLL) patients with high-risk cytogenetic features.

Inclusion Criteria:
•Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
•At least one high-risk cytogenetic feature defined by the presence of 17p deletion, 11q deletion and/or p53 mutation
•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)
•Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's tyrosine kinase (BTK)
Phase III
Cancer, All Other
John Pagel, M.D.
TG Therapeutics, Inc.
Neil Bailey
  • Swedish Medical Center