Trial Outcomes & Findings for Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma (NCT NCT03828448)
NCT ID: NCT03828448
Last Updated: 2023-07-24
Results Overview
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.
TERMINATED
PHASE2
34 participants
Up to 22 months
2023-07-24
Participant Flow
A total of 34 participants were enrolled at 3 investigative sites in the United States from 10 July 2019 to 31 May 2022.
Participant milestones
| Measure |
Ublituximab + Umbralisib
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.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Ublituximab + Umbralisib
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.
|
|---|---|
|
Overall Study
Sponsor's Discretion
|
34
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ublituximab + Umbralisib
n=34 Participants
Participants were administered ublituximab, 900 mg, 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.
|
|---|---|
|
Age, Continuous
|
70 years
n=34 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=34 Participants
|
PRIMARY outcome
Timeframe: Up to 22 monthsPopulation: Data for this outcome measure was not collected or analyzed as planned as the study was terminated due to sponsor's business decision.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 35 monthsPopulation: Data for this outcome measure was not collected or analyzed as planned as the study was terminated due to sponsor's business decision.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 35 monthsPopulation: Data for this outcome measure was not collected or analyzed as planned as the study was terminated due to sponsor's business decision.
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.
Outcome measures
Outcome data not reported
Adverse Events
Ublituximab + Umbralisib
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
TG Therapeutics Clinical Support Team
TG Therapeutics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place