GENUINE: Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02301156
Collaborator
(none)
126
Enrollment
81
Locations
2
Arms
62.1
Actual Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone in previously treated Chronic Lymphocytic Leukemia (CLL) patients with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jan 27, 2015
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Apr 1, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Ublituximab + ibrutinib

Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose

Drug: Ublituximab
Ublituximab IV infusion

Drug: ibrutinib
Ibrutinib oral daily dose
Other Names:
  • IMBRUVICA
  • Active Comparator: Ibrutinib

    - Ibrutinib: Fixed oral daily dose

    Drug: ibrutinib
    Ibrutinib oral daily dose
    Other Names:
  • IMBRUVICA
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate [Every 8-12 weeks, up to 2 years]

      To assess the overall response rate (ORR) in patients with Chronic Lymphocytic Leukemia treated with ublituximab in combination with ibrutinib compared to ibrutinib alone

    2. Progression-Free Survival [From date of randomization until the date of first documented progression, assessed up through 3 years]

      To assess the progression-free survival (PFS) in patients with Chronic Lymphocytic Leukemia treated with ublituximab in combination with ibrutinib compared to ibrutinib alone

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 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)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1TG Therapeutics Investigational Trial SiteHuntsvilleAlabamaUnited States35805
    2TG Therapeutics Investigational Trial SiteMobileAlabamaUnited States36604
    3TG Therapeutics Investigational Trial SiteChandlerArizonaUnited States85224
    4TG Therapeutics Investigational Trial SiteTucsonArizonaUnited States85710
    5TG Therapeutics Investigational Trial SiteFayettevilleArkansasUnited States72703
    6TG Therapeutics Investigational Trial SiteFullertonCaliforniaUnited States92835
    7TG Therapeutics Investigational Trial SiteGreenbraeCaliforniaUnited States94904
    8TG Therapeutics Investigational Trial SiteLos AngelesCaliforniaUnited States90045
    9TG Therapeutics Investigational Trial SitePismo BeachCaliforniaUnited States93449
    10TG Therapeutics Investigational Trial SitePleasantonCaliforniaUnited States94588
    11TG Therapeutics Investigational Trial SiteSanta BarbaraCaliforniaUnited States93105
    12TG Therapeutics Investigational Trial SiteAuroraColoradoUnited States80012
    13TG Therapeutics Investigational Trial SiteBridgeportConnecticutUnited States06606
    14TG Therapeutics Investigational Trial SiteStamfordConnecticutUnited States06904
    15TG Therapeutics Investigational Trial SiteNewarkDelawareUnited States19173
    16TG Therapeutics Investigational Trial SiteBoca RatonFloridaUnited States33486
    17TG Therapeutics Investigational Trial SiteFort MyersFloridaUnited States33905
    18TG Therapeutics Investigational Trial SiteOrange CityFloridaUnited States32763
    19TG Therapeutics Investigational Trial SitePensacolaFloridaUnited States32504
    20TG Therapeutics Investigational Trial SiteWest Palm BeachFloridaUnited States33401
    21TG Therapeutics Investigational Trial SiteAlbanyGeorgiaUnited States31701
    22TG Therapeutics Investigational Trial SiteNewnanGeorgiaUnited States30265
    23TG Therapeutics Investigational Trial SiteEvanstonIllinoisUnited States60201
    24TG Therapeutics Investigational Trial SiteNilesIllinoisUnited States60714
    25TG Therapeutics Investigational Trial SiteUrbanaIllinoisUnited States61801
    26TG Therapeutics Investigational Trial SiteFort WayneIndianaUnited States46804
    27TG Therapeutics Investigational Trial SiteIndianapolisIndianaUnited States46237
    28TG Therapeutics Investigational Trial SiteAmesIowaUnited States50010
    29TG Therapeutics Investigational Trial SiteCedar RapidsIowaUnited States52403
    30TG Therapeutics Investigational Trial SiteWestwoodKansasUnited States66205
    31TG Therapeutics Investigational Trial SiteNew OrleansLouisianaUnited States70121
    32TG Therapeutics Investigational Trial SiteBaltimoreMarylandUnited States21202
    33TG Therapeutics Investigational Trial SiteBaltimoreMarylandUnited States21215
    34TG Therapeutics Investigational Trial SiteBethesdaMarylandUnited States20817
    35TG Therapeutics Investigational Trial SiteColumbiaMarylandUnited States21044
    36TG Therapeutics Investigational Trial SiteSalisburyMarylandUnited States21801
    37TG Therapeutics Investigational Trial SiteBostonMassachusettsUnited States02111
    38TG Therapeutics Investigational Trial SiteSpringfieldMassachusettsUnited States01199
    39TG Therapeutics Investigational Trial SiteWorcesterMassachusettsUnited States01608
    40TG Therapeutics Investigational Trial SiteDetroitMichiganUnited States48202
    41TG Therapeutics Investigational Trial SiteCoon RapidsMinnesotaUnited States55433
    42TG Therapeutics Investigational Trial SiteSaint Louis ParkMinnesotaUnited States55416
    43TG Therapeutics Investigational Trial SiteLincolnNebraskaUnited States68510
    44TG Therapeutics Investigational Trial SiteOmahaNebraskaUnited States68130
    45TG Therapeutics Investigational Trial SiteLebanonNew HampshireUnited States03756
    46TG Therapeutics Investigational Trial SiteEast BrunswickNew JerseyUnited States08816
    47TG Therapeutics Investigational Trial SiteHowellNew JerseyUnited States07731
    48TG Therapeutics Investigational Trial SiteMorristownNew JerseyUnited States07962
    49TG Therapeutics Investigational Trial SitePompton PlainsNew JerseyUnited States07444
    50TG Therapeutics Investigational Trial SiteSomervilleNew JerseyUnited States08876
    51TG Therapeutics Investigational Trial SiteNew YorkNew YorkUnited States10019
    52TG Therapeutics Investigational Trial SiteSyracuseNew YorkUnited States13210
    53TG Therapeutics Investigational Trial SiteCharlotteNorth CarolinaUnited States28204
    54TG Therapeutics Investigational Trial SiteDurhamNorth CarolinaUnited States27710
    55TG Therapeutics Investigational Trial SiteRaleighNorth CarolinaUnited States27607
    56TG Therapeutics Investigational Trial SiteCantonOhioUnited States44718
    57TG Therapeutics Investigational Trial SiteCincinnatiOhioUnited States45242
    58TG Therapeutics Investigational Trial SiteClevelandOhioUnited States44106
    59TG Therapeutics Investigational Trial SitePortlandOregonUnited States97213-2982
    60TG Therapeutics Investigational Trial SitePortlandOregonUnited States97227
    61TG Therapeutics Investigational Trial SiteSpringfieldOregonUnited States97477
    62TG Therapeutics Investigational Trial SiteCamp HillPennsylvaniaUnited States17011
    63TG Therapeutics Investigational Trial SitePhiladelphiaPennsylvaniaUnited States19104
    64TG Therapeutics Investigational Trial SitePawtucketRhode IslandUnited States02860
    65TG Therapeutics Investigational Trial SiteGreenvilleSouth CarolinaUnited States29607
    66TG Therapeutics Investigational Trial SiteGreenvilleSouth CarolinaUnited States29615
    67TG Therapeutics Investigational Trial SiteSioux FallsSouth DakotaUnited States57105
    68TG Therapeutics Investigational Trial SiteWatertownSouth DakotaUnited States57201
    69TG Therapeutics Investigational Trial SiteMemphisTennesseeUnited States38120
    70TG Therapeutics Investigational Trial SiteNashvilleTennesseeUnited States37203
    71TG Therapeutics Investigational Trial SiteAustinTexasUnited States78705
    72TG Therapeutics Investigational Trial SiteDallasTexasUnited States75230
    73TG Therapeutics Investigational Trial SiteFort Sam HoustonTexasUnited States78234
    74TG Therapeutics Investigational Trial SiteSan AntonioTexasUnited States78229
    75TG Therapeutics Investigational Trial SiteTylerTexasUnited States75702
    76TG Therapeutics Investigational Trial SiteWebsterTexasUnited States77598-4420
    77TG Therapeutics Investigational Trial SiteBlacksburgVirginiaUnited States24060
    78TG Therapeutics Investigational Trial SiteRichmondVirginiaUnited States23230
    79TG Therapeutics Investigational Trial SiteSeattleWashingtonUnited States98104
    80TG Therapeutics Investigational Trial SiteSpokaneWashingtonUnited States99216
    81TG Therapeutics Investigational Trial SiteVancouverWashingtonUnited States98683

    Sponsors and Collaborators

    • TG Therapeutics, Inc.

    Investigators

    • Study Chair: Jeff Sharman, MD, Willamette Valley Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02301156
    Other Study ID Numbers:
    • UTX-IB-301
    First Posted:
    Nov 25, 2014
    Last Update Posted:
    Dec 20, 2021
    Last Verified:
    Dec 1, 2021

    Study Results

    No Results Posted as of Dec 20, 2021