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

Phase 2TerminatedNCT03828448

TG Therapeutics, Inc.34 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Follicular Lymphoma Small Lymphocytic Lymphoma

Interventions

UblituximabDRUG

\- anti-CD 20 monoclonal antibody administered via IV infusion

UmbralisibDRUG

\- PI3K Delta Inhibitor oral daily dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

TG Therapeutics Investigational Trial Site

Fort Myers, Florida, United States

TG Therapeutics Investigational Trial Site

St. Petersburg, Florida, United States

TG Therapeutics Investigational Trial Site

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

ORR was defined as sum of participants with partial responses (PR) and complete responses (CR). CR was defined as complete disappearance of all evidence of disease and disease-related symptoms. PR was defined as regression of measurable disease and no new sites of disease. Regression= ≥ 50% decrease in sum of the products of diameters (SPD) of index lesions, with no unequivocal increase in size of other lymph nodes, liver, or spleen.

Time frame: Up to 22 months

Secondary Outcomes

Progression-Free Survival (PFS)

PFS was defined as the interval from Cycle 1/Day 1 to the earlier of the first documentation of definitive disease progression or death from any cause. Appearance of any new lesion more than 1.5 cm in any axis, even if other lesions were decreasing in size was considered relapsed or progressive disease. At least a 50% increase from nadir in one of the following: SPD of index lesions, greatest transverse diameter (GTD) of any individual previously involved node, or GTD of any previously involved node provided that the GTD of that node was ≥ 1.5 cm.

Time frame: Up to approximately 35 months

Number of Participants With Treatment-emergent Adverse Events (TEAE) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0

An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is an AE that starts or worsens after receiving study drug.

Time frame: Up to approximately 35 months

Data from ClinicalTrials.gov

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