NCT03828448

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: TG Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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).

Conditions

• Follicular Lymphoma
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	Ublituximab	\- anti-CD 20 monoclonal antibody administered via IV infusion
DRUG	Umbralisib	\- PI3K Delta Inhibitor oral daily dose

Timeline

• Start date: 2019-07-10
• Primary completion: 2022-05-16
• Completion: 2022-05-31
• First posted: 2019-02-04
• Last updated: 2023-07-24
• Results posted: 2023-07-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study