Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma

A Phase II Study Evaluating the Safety and Efficacy of Umbralisib (TGR-1202) in Combination With Ublituximab in Patients With Treatment Naïve Follicular Lymphoma and Small Lymphocytic Lymphoma

This is a phase 2, open label study to assess umbralisib in combination with ublituximab in participants with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).

The study will assess the safety and efficacy of umbralisib in combination with ublituximab in participants with treatment naïve FL and SLL. Ublituximab will be administered through Cycle 12, while umbralisib will be administered through Cycle 24. After this time, participants will be followed for progression free survival (PFS).

Inclusion Criteria:

• Confirmed diagnosis of FL or SLL.
• Measurable disease that requires treatment
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

• Currently or previously received treatment for their lymphoma
• Received wide field radiotherapy within 28 days or limited field radiation within 14 days of Cycle 1 Day 1
• Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection