TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil in patients with chronic lymphocytic leukemia.

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

Details

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

Criteria

Inclusion Criteria:

• Confirmed Chronic Lymphocytic Leukemia (CLL)

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

• Ability to swallow oral medication

Exclusion Criteria:

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

• Primary central nervous system lymphoma or known intracranial involvement

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