Clinical trial NCT02612311: Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
Official title: Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 (Umbralisib) Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-23
Enrollment: 603
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) participants.


Eligibility criteria: Inclusion Criteria:

* Treatment naïve or previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

* Any major surgery, chemotherapy or immunotherapy within the last 21 days
* Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
* Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
* Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
* Prior therapy with obinutuzumab and/or chlorambucil or a PI3K delta inhibitor

Primary outcomes:
measure: Progression-Free Survival (PFS) Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria
timeFrame: From enrolment to the earlier of the first documentation of definitive disease progression (PD) or death (Up to 87 months)
Secondary outcomes:
measure: Overall Response Rate (ORR) Per iwCLL Criteria
timeFrame: Up to 87 months
measure: Complete Response (CR) Rate
timeFrame: Up to 87 months
measure: Minimal Residual Disease (MRD) Negativity Rate
timeFrame: From Cycle 6 until Cycle 15 (cycle length=28 days) up to approximately 81.5 months
measure: Duration of Response (DOR)
timeFrame: From first documentation of response to study treatment till disease progression/death (up to approximately 87 months)
measure: Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: From first dose of study treatment up to end of study (up to approximately 87 months)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Alabama
city: Mobile
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: Phoenix
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arizona
city: Tucson
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: Concord
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Duarte
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Greenbrae
country: United States
facility: TG Therapeutics Investigational Trial Site
state: California
city: Pismo Beach
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: Santa Barbara
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: Ocala
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Florida
city: Pensacola
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: Tampa
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: Macon
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: Decatur
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Maywood
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Illinois
city: Niles
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: Ames
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Iowa
city: Cedar Rapids
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Iowa
city: Kansas City
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kansas
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: Baltimore
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maryland
city: Baltimore
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maryland
city: Bethesda
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maryland
city: Columbia
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Maryland
city: Boston
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Massachusetts
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: Columbia
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Missouri
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: Las Vegas
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Nevada
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: Somerville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: East Setauket
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New York
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: Raleigh
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: Cincinnati
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: Danville
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: 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: Watertown
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: Austin
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Bedford
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Fort Worth
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Houston
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: San Antonio
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Tyler
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: Olympia
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Seattle
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
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: Vancouver
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Yakima
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Milwaukee
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Wisconsin
city: Wauwatosa
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Wisconsin
city: Ashkelon
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Be'er Sheva
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Haifa
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Jerusalem
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Nahariya
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Petah tikva
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Tel Aviv
country: Israel
facility: TG Therapeutics Investigational Trial Site
city: Bologna
country: Italy
facility: TG Therapeutics Investigational Trial Site
city: Ferrara
country: Italy
facility: TG Therapeutics Investigational Trial Site
city: Milan
country: Italy
facility: TG Therapeutics Investigational Trial Site
city: Rome
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: Krakow
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: Wroclaw
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Łódź
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Krasnozatonskiy
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Moscow
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Perm
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Petrozavodsk
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Rodionova
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Saint Petersburg
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Smolensk
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Tula
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Yaroslavl
country: Russian Federation
facility: TG Therapeutics Investigational Trial Site
city: Barcelona
country: Spain
facility: TG Therapeutics Investigational Trial Site
city: Madrid
country: Spain
facility: TG Therapeutics Investigational Trial Site
city: Valencia
country: Spain
facility: TG Therapeutics Investigational Trial Site
city: Cambridge
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Cumbria
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Dudley West
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: London
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Northbrook
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Northumbria
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Norwich
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Peterborough
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: Southampton
country: United Kingdom
facility: TG Therapeutics Investigational Trial Site
city: St. James
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: