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

Follicular Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03828448
• Other study ID #: UTX-TGR-203
• Status: Terminated
• Phase: Phase 2
• Start date: July 10, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2023
• Source: TG Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: May 31, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, Follicular
• Small Lymphocytic Lymphoma

Intervention

Drug:
• Ublituximab
- anti-CD 20 monoclonal antibody administered via IV infusion
• Umbralisib
- PI3K Delta Inhibitor oral daily dose

Locations

Country	Name	City	State
United States	TG Therapeutics Investigational Trial Site	Fort Myers	Florida
United States	TG Therapeutics Investigational Trial Site	Nashville	Tennessee
United States	TG Therapeutics Investigational Trial Site	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
TG Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to approximately 35 months
Secondary	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.	Up to approximately 35 months