Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Patients With Untreated and Previously Treated Chronic Lymphocytic Leukemia

• Status: Active, not recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: TG Therapeutics, Inc.
• Treatments: Antibodies, Monoclonal; Chlorambucil; Obinutuzumab

Criteria

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