The main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior BTK (Bruton Tyrosine Kinase) inhibitors (ibrutinib, ACP-196, other) or prior PI3K-delta inhibitors (idelalisib, duvelisib, other).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Umbralisib was administered as a tablet(s), orally once daily.
TG Therapeutics Investigational Trial Site
Huntsville, Alabama, United States
TG Therapeutics Investigational Trial Site
Washington D.C., District of Columbia, United States
Progression-free Survival
PFS was defined as the interval from Day 1 to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. Participants who had no event (progression or death) were censored at the day of their last adequate disease assessment.
Time frame: From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months)
Overall Response Rate (ORR)
ORR=percent of participants who achieve complete response (CR), or partial response (PR).
Time frame: Up to 61.7 months
Time to Treatment Failure (TTF)
TTF is defined as a composite endpoint measuring time from Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. Estimates of median TTF was made using Kaplan-Meier methods.
Time frame: From Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death (up to approximately 61.7 months)
Duration of Response (DOR)
DOR defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause. Estimates of median DOR was made using Kaplan-Meier methods.
Time frame: From first documentation of CR or PR till disease progression/death (up to approximately 61.7 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAE's) as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this treatment. An AE can therefore be 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. TEAE is any AE that occur after first dosing of study medication and through the end of the study or through 30 days after the last dose of study treatment, or is considered treatment-related regardless of the start date of the event, or is present before first dosing of study medication but worsens in intensity or the investigator subsequently considers treatment-related. TEAEs included both serious and non-serious TEAEs.
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TG Therapeutics Investigational Trial Site
Fort Myers, Florida, United States
TG Therapeutics Investigational Trial Site
St. Petersburg, Florida, United States
TG Therapeutics Investigational Trial Site
Kansas City, Missouri, United States
TG Therapeutics Investigational Trial Site
Lebanon, New Hampshire, United States
TG Therapeutics Investigational Trial Site
Hackensack, New Jersey, United States
TG Therapeutics Investigational Trial Site
New Hyde Park, New York, United States
TG Therapeutics Investigational Trial Site
New York, New York, United States
TG Therapeutics Investigational Trial Site
Rochester, New York, United States
...and 5 more locations
Time frame: From first dose of study treatment up to end of study (up to 61.7 months)