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

A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of TGR-1202, a Novel PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)

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.

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