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

TG Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Small Lymphocytic Lymphoma; Follicular Lymphoma

Treatments: Drug: Umbralisib; Drug: Ublituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03828448

UTX-TGR-203

Details and patient eligibility

About

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).

Full 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).

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Ublituximab + Umbralisib

Experimental group

Description:

Participants were administered ublituximab, 900 milligrams (mg), intravenous (IV) infusion through Cycles 1-6, Cycles 9 and 12. Participants also received umbralisib, 800 mg, oral tablet, daily through Cycles 1-24. 1 Cycle = 28 days.

Treatment:

Drug: Ublituximab

Drug: Umbralisib