Clinical trial NCT02301156: Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
Official title: A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination With Ibrutinib Compared to Ibrutinib Alone, in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-25
Enrollment: 126
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 effect of the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall response rate (ORR = CR \[complete response\] + PR \[partial response\]) in previously treated Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.


Eligibility criteria: Inclusion Criteria:

* Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
* At least one high-risk cytogenetic feature defined by the presence of 17p deletion, 11q deletion and/or p53 mutation
* 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 human immunodeficiency virus (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)
* Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's tyrosine kinase (BTK)

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 62 months
Secondary outcomes:
measure: Complete Response (CR) Rate
timeFrame: Up to 62 months
measure: Minimum Residual Disease (MRD) Negativity Rate
timeFrame: Up to 62 months
measure: Progression-Free Survival (PFS)
timeFrame: From the randomization until the first documentation of PD or death whichever occurs first or up to 62 months
measure: Duration of Response (DOR)
timeFrame: From the first dose of study drug until the first documentation of PD or death whichever occurs first or up to 62 months
measure: Time to Response (TTR)
timeFrame: From the randomization up to 62 months
measure: Percentage of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: From the first dose up to 30 days after the last dose of study drug (up to 57.3 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: 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: Jonesboro
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arkansas
city: Fullerton
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: Los Angeles
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: Santa Barbara
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: Bridgeport
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: Orange City
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: 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: Newnan
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Georgia
city: Evanston
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: 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: Westwood
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Kansas
city: Baton Rouge
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Louisiana
city: New Orleans
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Louisiana
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: Salisbury
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: Springfield
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: Detroit
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Michigan
city: Coon Rapids
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Minnesota
city: Saint Louis Park
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Minnesota
city: Lincoln
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Nebraska
city: Omaha
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: East Brunswick
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Howell
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Morristown
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Pompton Plains
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: New York
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: Raleigh
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: Cleveland
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: Philadelphia
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: 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: Memphis
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: Dallas
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Denton
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Fort Sam 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: Tyler
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
city: Webster
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: Richmond
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: Vancouver
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Washington
city: Ashkelon
country: Israel
facility: TG Therapeutics Investigational Trial Site
Study officials:
affiliation: Willamette Valley Cancer Institute
name: Jeff Sharman, MD
role: STUDY_CHAIR
References:
citation: Sharman JP, Brander DM, Mato AR, Ghosh N, Schuster SJ, Kambhampati S, Burke JM, Lansigan F, Schreeder MT, Lunin SD, Zweibach A, Shtivelband M, Travis PM, Chandler JC, Kolibaba KS, Sportelli P, Miskin HP, Weiss MS, Flinn IW. Ublituximab plus ibrutinib versus ibrutinib alone for patients with relapsed or refractory high-risk chronic lymphocytic leukaemia (GENUINE): a phase 3, multicentre, open-label, randomised trial. Lancet Haematol. 2021 Apr;8(4):e254-e266. doi: 10.1016/S2352-3026(20)30433-6. Epub 2021 Feb 22.