Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy
- Registration Number
- NCT02742090
- Lead Sponsor
- TG Therapeutics, Inc.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 51
- Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
- Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months
- Presence of measurable disease
- Progression on prior BTK or PI3K delta inhibitor
- Prior treatment with TGR-1202
- Richter's transformation or CLL transformation to aggressive lymphoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Umbralisib Umbralisib Participants received 800 milligrams (mg) of umbralisib, orally, once daily until disease progression, unacceptable toxicity or the end of the study for 60.7 months.
- Primary Outcome Measures
Name Time Method Progression-free Survival From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months) 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.
- Secondary Outcome Measures
Name Time Method Time to Treatment Failure (TTF) From Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death (up to approximately 61.7 months) 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.
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) From first dose of study treatment up to end of study (up to 61.7 months) 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.
Duration of Response (DOR) From first documentation of CR or PR till disease progression/death (up to approximately 61.7 months) 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.
Overall Response Rate (ORR) Up to 61.7 months ORR=percent of participants who achieve complete response (CR), or partial response (PR).
Trial Locations
- Locations (1)
TG Therapeutics Investigational Trial Site
🇺🇸Seattle, Washington, United States