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
Verified date | July 2023 |
Source | TG Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
TG Therapeutics, Inc. |
United States,
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 |
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