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

NCT03828448 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: UTX-TGR-203
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Follicular Lymphoma; Small Lymphocytic Lymphoma

Keywords

Treatment naïve

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 22 months

Secondary Outcomes (2)

• Progression-Free Survival (PFS)

  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

  Up to approximately 35 months

Study Arms (1)

Ublituximab + Umbralisib

EXPERIMENTAL

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.

Drug: Ublituximab; Drug: Umbralisib

Interventions

Ublituximab DRUG

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

Also known as: TG-1101

Ublituximab + Umbralisib

Umbralisib DRUG

\- PI3K Delta Inhibitor oral daily dose

Also known as: TGR-1202

Ublituximab + Umbralisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• TG Therapeutics, Inc.: lead

Study Sites (3)

TG Therapeutics Investigational Trial Site

Fort Myers, Florida, 33901, United States

Location

TG Therapeutics Investigational Trial Site

St. Petersburg, Florida, 33705, United States

Location

TG Therapeutics Investigational Trial Site

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

ublituximab; umbralisib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to sponsor's business decision, the clinical trial was terminated by the sponsor prematurely. No analysis was done at the termination of the trial, therefore, outcome, and safety data are not available and the numbers of participants analyzed are reported as "0."

Results Point of Contact

• Title: TG Therapeutics Clinical Support Team
• Organization: TG Therapeutics

clinicalsupport@tgtxinc.com

1-877-575-8489

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 4, 2019
• Study Start: July 10, 2019
• Primary Completion: May 16, 2022
• Study Completion: May 31, 2022
• Last Updated: July 24, 2023
• Results First Posted: July 24, 2023

Record last verified: 2023-07

Locations

US (3)