Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TG Therapeutics, Inc.
• Collaborators: Abramson Cancer Center of the University of Pennsylvania; Memorial Sloan Kettering Cancer Center
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation

• Refractory to or relapsed after at least 1 prior treatment regimen

• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

• Any major surgery, chemotherapy or immunotherapy within the last 14 days

• Known hepatitis B virus, hepatitis C virus or HIV infection

• Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)