Back to resultsStudy to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma
Primary Purpose
Follicular Lymphoma, Small Lymphocytic Lymphoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ublituximab
Umbralisib
Sponsored by
About this trial
This is an interventional treatment trial for Follicular Lymphoma focused on measuring Treatment naïve
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of Follicular Lymphoma (FL) or Small Lymphocytic Lymphoma (SLL).
- Measurable disease that requires treatment
- 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 HIV infection
Sites / Locations
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ublituximab + Umbralisib
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03828448
Brief Title
Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Strategic/Business Decision
Study Start Date
July 10, 2019 (Actual)
Primary Completion Date
May 16, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma, Small Lymphocytic Lymphoma
Keywords
Treatment naïve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ublituximab + Umbralisib
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ublituximab
Other Intervention Name(s)
TG-1101
Intervention Description
- anti-CD 20 monoclonal antibody administered via IV infusion
Intervention Type
Drug
Intervention Name(s)
Umbralisib
Other Intervention Name(s)
TGR-1202
Intervention Description
- PI3K Delta Inhibitor oral daily dose
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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 Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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
Title
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
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma
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