Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

• Status: Completed
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TG Therapeutics, Inc.

Criteria

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)