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.
•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
•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)
John Pagel, M.D.
TG Therapeutics, Inc.