Clinical trial NCT02742090: Evaluate the Efficacy and Safety of TGR-1202 in Participants With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy
Official title: A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 (Umbralisib) in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-Delta Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Progression on prior BTK or PI3K delta inhibitor
* Prior treatment with TGR-1202
* Richter's transformation or CLL transformation to aggressive lymphoma

Primary outcomes:
measure: Progression-free Survival
timeFrame: From Day 1 to the earlier of the first documentation of definitive disease progression or death (Up to 61.7 months)
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 61.7 months
measure: Time to Treatment Failure (TTF)
timeFrame: From Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death (up to approximately 61.7 months)
measure: Duration of Response (DOR)
timeFrame: From first documentation of CR or PR till disease progression/death (up to approximately 61.7 months)
measure: 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)
timeFrame: From first dose of study treatment up to end of study (up to 61.7 months)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Alabama
city: Washington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: District of Columbia
city: Fort Myers
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Saint Petersburg
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Kansas City
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Missouri
city: Lebanon
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Hampshire
city: Hackensack
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: New Hyde Park
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: New York
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: Rochester
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: Durham
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Hershey
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Pennsylvania
city: Nashville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Seattle
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
Study officials:
affiliation: University of Pennsylvania Center for CLL
name: Anthony Mato, MD
role: STUDY_CHAIR
References:
citation: Mato AR, Nabhan C, Barr PM, Ujjani CS, Hill BT, Lamanna N, Skarbnik AP, Howlett C, Pu JJ, Sehgal AR, Strelec LE, Vandegrift A, Fitzpatrick DM, Zent CS, Feldman T, Goy A, Claxton DF, Bachow SH, Kaur G, Svoboda J, Nasta SD, Porter D, Landsburg DJ, Schuster SJ, Cheson BD, Kiselev P, Evens AM. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience. Blood. 2016 Nov 3;128(18):2199-2205. doi: 10.1182/blood-2016-05-716977. Epub 2016 Sep 6.