Clinical trial NCT02656303: A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304
Official title: A Multi-Center, Open-Label, Compassionate Use Extension Study of Ublituximab (TG-1101) in Combination With Umbralisib (TGR-1202) for Patients Previously Enrolled in Protocol UTX-TGR-304
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-14
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to provide the opportunity to the participants who progressed on treatment arm previously in the study UTX-TGR-304 (NCT02612311) to receive ublituximab (TG-1101) treatment in combination with umbralisib (TGR-1202).


Eligibility criteria: Inclusion Criteria:

* Prior treatment in clinical trial UTX-TGR-304
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

* Participants refractory to ublituximab + TGR-1202
* Transformation of chronic lymphocytic leukemia (CLL) to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)

Primary outcomes:
measure: Overall Response Rate (ORR) as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria
timeFrame: Up to 76 months
measure: Complete Response (CR) Rate Per iwCLL Criteria
timeFrame: Up to 76 months
measure: Progression-Free Survival (PFS) Per iwCLL Criteria
timeFrame: Up to 76 months
measure: Duration of Response (DOR)
timeFrame: Up to 76 months
Secondary outcomes:
measure: Minimal Residual Disease (MRD) Negativity Rate
timeFrame: From Cycle 6 until Cycle 15 (cycle length=28 days) (Up to approximately 76 months)
measure: Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to 78 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Alabama
city: Chandler
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arizona
city: Fayetteville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arkansas
city: Duarte
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Pleasanton
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: San Diego
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Whittier
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Aurora
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Denver
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Colorado
city: Bridgeport
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Connecticut
city: New Haven
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Connecticut
city: Stamford
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Connecticut
city: Newark
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Delaware
city: Boca Raton
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Fort Myers
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Jacksonville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Jacksonville
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: Tallahassee
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: West Palm Beach
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Albany
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Georgia
city: Chicago
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Peoria
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Swansea
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Urbana
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Fort Wayne
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Indiana
city: Indianapolis
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Indiana
city: Westwood
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kansas
city: Louisville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kentucky
city: Worcester
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Michigan
city: Detroit
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Michigan
city: Jackson
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Michigan
city: Saint Louis Park
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Minnesota
city: Kansas City
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Missouri
city: Lincoln
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Nebraska
city: Lebanon
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Hampshire
city: Morristown
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Glens Falls
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: Syracuse
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
city: Charlotte
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Durham
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Durham
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Hickory
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Kinston
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Washington
country: United States
facility: TG Therapeutics Investigational Trial Site
state: North Carolina
city: Canton
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Toledo
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Ohio
city: Portland
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Oregon
city: Portland
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Oregon
city: Springfield
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Oregon
city: Camp Hill
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Pennsylvania
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: Pittsburgh
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Pennsylvania
city: Pawtucket
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Rhode Island
city: Greenville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: South Carolina
city: Sioux Falls
country: United States
facility: TG Therapeutics Investigational Trial Site
state: South Dakota
city: Chattanooga
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Nashville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Fort Worth
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: San Antonio
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Ogden
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Utah
city: Blacksburg
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Virginia
city: Charlottesville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Virginia
city: Fort Belvoir
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Virginia
city: Seattle
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Spokane
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Wauwatosa
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Wisconsin
city: Ferrara
country: Italy
facility: TG Therapeutics Investigational Trial Site
city: Milan
country: Italy
facility: TG Therapeutics Investigational Trial Site
city: Milan
country: Italy
facility: TG Therapeutics Investigational Trial Site
city: Torino
country: Italy
facility: TG Therapeutics Investigational Trial Site
city: Chorzów
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Gdynia
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Kraków
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Lublin
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Słupsk
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Warszawa
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Warszawa
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Warszawa
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Warszawa
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Łódź
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: London
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Norwich
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Sunderland
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Wolverhampton
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
Study officials:
References: