Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies

• Status: Completed
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with advanced hematologic malignancies

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

Details

• Lead Sponsor: TG Therapeutics, Inc.
• Treatments: Antibodies, Monoclonal; Bendamustine Hydrochloride

Criteria

Inclusion Criteria:

• Confirmed B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and other B-cell lymphoproliferative disorders as approved by the Medical Monitor or Study Chair

• 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 21 days

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

• Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months

• Primary central nervous system lymphoma or known intracranial involvement