UNITY-CLL: Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Patients With Untreated and Previously Treated Chronic Lymphocytic Leukemia

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02612311
Collaborator
(none)
600
Enrollment
154
Locations
4
Arms
97.4
Anticipated Duration (Months)
3.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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) patients.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 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 TGR-1202 Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
Actual Study Start Date :
Nov 19, 2015
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Ublituximab + TGR-1202

Ublituximab: IV infusion dose on Days 1, 8 and 15 followed by maintenance infusions TGR-1202: Fixed oral daily dose

Biological: Ublituximab
Ublituximab: IV infusion

Drug: TGR-1202
TGR-1202: Oral daily dose

Active Comparator: Obinutuzumab + Chlorambucil

Obinutuzumab: IV infusion dose on Days 1, 8 and 15 in Cycle 1 followed by Day 1 infusion in Cycles 2 - 6 Chlorambucil: Oral dose on Days 1 and 15 of Cycles 1 - 6

Biological: Obinutuzumab
Obinutuzumab: IV infusion
Other Names:
  • GAZYVA
  • Drug: Chlorambucil
    Chlorambucil: Oral dose
    Other Names:
  • Leukeran
  • Experimental: Ublituximab

    - Ublituximab: IV infusion dose on Days 1, 8 and 15 followed by maintenance infusions

    Biological: Ublituximab
    Ublituximab: IV infusion

    Experimental: TGR-1202

    - TGR-1202: Fixed oral daily dose

    Drug: TGR-1202
    TGR-1202: Oral daily dose

    Outcome Measures

    Primary Outcome Measures

    1. 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 TGR-1202 compared to obinutuzumab + chlorambucil

    Secondary Outcome Measures

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

      To assess the overall response rate (ORR) in patients with Chronic Lymphocytic Leukemia treated with ublituximab + TGR-1202 compared to ublituximab and TGR-1202 alone

    Eligibility Criteria

    Criteria

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

    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 SitePhoenixArizonaUnited States85016
    5TG Therapeutics Investigational Trial SiteTucsonArizonaUnited States85711
    6TG Therapeutics Investigational Trial SiteFayettevilleArkansasUnited States72703
    7TG Therapeutics Investigational Trial SiteConcordCaliforniaUnited States94520
    8TG Therapeutics Investigational Trial SiteDuarteCaliforniaUnited States91010
    9TG Therapeutics Investigational Trial SiteGreenbraeCaliforniaUnited States94904
    10TG Therapeutics Investigational Trial SitePismo BeachCaliforniaUnited States93449
    11TG Therapeutics Investigational Trial SitePleasantonCaliforniaUnited States94588
    12TG Therapeutics Investigational Trial SiteSan DiegoCaliforniaUnited States92120
    13TG Therapeutics Investigational Trial SiteSanta BarbaraCaliforniaUnited States93105
    14TG Therapeutics Investigational Trial SiteWhittierCaliforniaUnited States90603
    15TG Therapeutics Investigational Trial SiteAuroraColoradoUnited States80012
    16TG Therapeutics Investigational Trial SiteDenverColoradoUnited States80218
    17TG Therapeutics Investigational Trial SiteBridgeportConnecticutUnited States06606
    18TG Therapeutics Investigational Trial SiteNew HavenConnecticutUnited States06519
    19TG Therapeutics Investigational Trial SiteStamfordConnecticutUnited States06904
    20TG Therapeutics Investigational Trial SiteNewarkDelawareUnited States19713
    21TG Therapeutics Investigational Trial SiteBoca RatonFloridaUnited States33486
    22TG Therapeutics Investigational Trial SiteFort MyersFloridaUnited States33916
    23TG Therapeutics Investigational Trial SiteJacksonvilleFloridaUnited States32204
    24TG Therapeutics Investigational Trial SiteJacksonvilleFloridaUnited States32256
    25TG Therapeutics Investigational Trial SiteOcalaFloridaUnited States34471
    26TG Therapeutics Investigational Trial SitePensacolaFloridaUnited States32504
    27TG Therapeutics Investigational Trial SiteSaint PetersburgFloridaUnited States33705
    28TG Therapeutics Investigational Trial SiteTallahasseeFloridaUnited States32308
    29TG Therapeutics Investigational Trial SiteTampaFloridaUnited States33612
    30TG Therapeutics Investigational Trial SiteWest Palm BeachFloridaUnited States33407
    31TG Therapeutics Investigational Trial SiteAlbanyGeorgiaUnited States31701
    32TG Therapeutics Investigational Trial SiteMaconGeorgiaUnited States31201
    33TG Therapeutics Investigational Trial SiteChicagoIllinoisUnited States60612
    34TG Therapeutics Investigational Trial SiteDecaturIllinoisUnited States62526
    35TG Therapeutics Investigational Trial SiteMaywoodIllinoisUnited States60153
    36TG Therapeutics Investigational Trial SiteNilesIllinoisUnited States60714
    37TG Therapeutics Investigational Trial SitePeoriaIllinoisUnited States61615
    38TG Therapeutics Investigational Trial SiteSwanseaIllinoisUnited States
    39TG Therapeutics Investigational Trial SiteUrbanaIllinoisUnited States61801
    40TG Therapeutics Investigational Trial SiteFort WayneIndianaUnited States46804
    41TG Therapeutics Investigational Trial SiteIndianapolisIndianaUnited States46237
    42TG Therapeutics Investigational Trial SiteAmesIowaUnited States50010
    43TG Therapeutics Investigational Trial SiteCedar RapidsIowaUnited States52403
    44TG Therapeutics Investigational Trial SiteKansas CityKansasUnited States64132
    45TG Therapeutics Investigational Trial SiteWestwoodKansasUnited States66210
    46TG Therapeutics Investigational Trial SiteLouisvilleKentuckyUnited States40207
    47TG Therapeutics Investigational Trial SiteBaltimoreMarylandUnited States21202
    48TG Therapeutics Investigational Trial SiteBaltimoreMarylandUnited States21215
    49TG Therapeutics Investigational Trial SiteBethesdaMarylandUnited States20817
    50TG Therapeutics Investigational Trial SiteColumbiaMarylandUnited States21044
    51TG Therapeutics Investigational Trial SiteBostonMassachusettsUnited States02111
    52TG Therapeutics Investigational Trial SiteWorcesterMassachusettsUnited States01608
    53TG Therapeutics Investigational Trial SiteAnn ArborMichiganUnited States48106
    54TG Therapeutics Investigational Trial SiteDetroitMichiganUnited States48202
    55TG Therapeutics Investigational Trial SiteJacksonMichiganUnited States49201
    56TG Therapeutics Investigational Trial SiteSaint Louis ParkMinnesotaUnited States55416
    57TG Therapeutics Investigational Trial SiteColumbiaMissouriUnited States65212
    58TG Therapeutics Investigational Trial SiteKansas CityMissouriUnited States
    59TG Therapeutics Investigational Trial SiteLincolnNebraskaUnited States68510
    60TG Therapeutics Investigational Trial SiteLas VegasNevadaUnited States89119
    61TG Therapeutics Investigational Trial SiteLebanonNew HampshireUnited States03756
    62TG Therapeutics Investigational Trial SiteMorristownNew JerseyUnited States07962
    63TG Therapeutics Investigational Trial SiteSomervilleNew JerseyUnited States00876
    64TG Therapeutics Investigational Trial SiteEast SetauketNew YorkUnited States11733
    65TG Therapeutics Investigational Trial SiteGlens FallsNew YorkUnited States12801
    66TG Therapeutics Investigational Trial SiteSyracuseNew YorkUnited States13210
    67TG Therapeutics Investigational Trial SiteCharlotteNorth CarolinaUnited States28204
    68TG Therapeutics Investigational Trial SiteDurhamNorth CarolinaUnited States27710
    69TG Therapeutics Investigational Trial SiteDurhamNorth CarolinaUnited States
    70TG Therapeutics Investigational Trial SiteHickoryNorth CarolinaUnited States28602
    71TG Therapeutics Investigational Trial SiteKinstonNorth CarolinaUnited States28501
    72TG Therapeutics Investigational Trial SiteRaleighNorth CarolinaUnited States27607
    73TG Therapeutics Investigational Trial SiteWashingtonNorth CarolinaUnited States27889
    74TG Therapeutics Investigational Trial SiteCantonOhioUnited States44718
    75TG Therapeutics Investigational Trial SiteCincinnatiOhioUnited States45236
    76TG Therapeutics Investigational Trial SiteToledoOhioUnited States43623
    77TG Therapeutics Investigational Trial SitePortlandOregonUnited States97227
    78TG Therapeutics Investigational Trial SitePortlandOregonUnited States97239
    79TG Therapeutics Investigational Trial SiteSpringfieldOregonUnited States97477
    80TG Therapeutics Investigational Trial SiteCamp HillPennsylvaniaUnited States17011
    81TG Therapeutics Investigational Trial SiteDanvillePennsylvaniaUnited States17822
    82TG Therapeutics Investigational Trial SiteHersheyPennsylvaniaUnited States17033
    83TG Therapeutics Investigational Trial SitePhiladelphiaPennsylvaniaUnited States19106
    84TG Therapeutics Investigational Trial SitePittsburghPennsylvaniaUnited States15224
    85TG Therapeutics Investigational Trial SitePittsburghPennsylvaniaUnited States15232
    86TG Therapeutics Investigational Trial SitePawtucketRhode IslandUnited States00286
    87TG Therapeutics Investigational Trial SiteGreenvilleSouth CarolinaUnited States29615
    88TG Therapeutics Investigational Trial SiteSioux FallsSouth DakotaUnited States57105
    89TG Therapeutics Investigational Trial SiteWatertownSouth DakotaUnited States57201
    90TG Therapeutics Investigational Trial SiteChattanoogaTennesseeUnited States37404
    91TG Therapeutics Investigational Trial SiteNashvilleTennesseeUnited States37203
    92TG Therapeutics Investigational Trial SiteAustinTexasUnited States78705
    93TG Therapeutics Investigational Trial SiteBedfordTexasUnited States76022
    94TG Therapeutics Investigational Trial SiteFort WorthTexasUnited States76104
    95TG Therapeutics Investigational Trial SiteHoustonTexasUnited States77030
    96TG Therapeutics Investigational Trial SiteSan AntonioTexasUnited States78217
    97TG Therapeutics Investigational Trial SiteSan AntonioTexasUnited States78229
    98TG Therapeutics Investigational Trial SiteTylerTexasUnited States75702
    99TG Therapeutics Investigational Trial SiteOgdenUtahUnited States84405
    100TG Therapeutics Investigational Trial SiteBlacksburgVirginiaUnited States24060
    101TG Therapeutics Investigational Trial SiteCharlottesvilleVirginiaUnited States22908
    102TG Therapeutics Investigational Trial SiteFort BelvoirVirginiaUnited States22060
    103TG Therapeutics Investigational Trial SiteOlympiaWashingtonUnited States98502
    104TG Therapeutics Investigational Trial SiteSeattleWashingtonUnited States98104
    105TG Therapeutics Investigational Trial SiteSeattleWashingtonUnited States98109
    106TG Therapeutics Investigational Trial SiteSpokaneWashingtonUnited States99216
    107TG Therapeutics Investigational Trial SiteVancouverWashingtonUnited States98684
    108TG Therapeutics Investigational Trial SiteYakimaWashingtonUnited States98902
    109TG Therapeutics Investigational Trial SiteMilwaukeeWisconsinUnited States53226
    110TG Therapeutics Investigational Trial SiteWauwatosaWisconsinUnited States53226
    111TG Therapeutics Investigational Trial SiteAshkelonIsrael
    112TG Therapeutics Investigational Trial SiteBe'er ShevaIsrael
    113TG Therapeutics Investigational Trial SiteHaifaIsrael
    114TG Therapeutics Investigational Trial SiteJerusalemIsrael
    115TG Therapeutics Investigational Trial SiteNahariyaIsrael
    116TG Therapeutics Investigational Trial SitePetah tikvaIsrael
    117TG Therapeutics Investigational Trial SiteTel AvivIsrael
    118TG Therapeutics Investigational Trial SiteBolognaItaly
    119TG Therapeutics Investigational Trial SiteFerraraItaly
    120TG Therapeutics Investigational Trial SiteMilanItaly
    121TG Therapeutics Investigational Trial SiteRomeItaly
    122TG Therapeutics Investigational Trial SiteTorinoItaly
    123TG Therapeutics Investigational Trial SiteChorzówPoland
    124TG Therapeutics Investigational Trial SiteGdyniaPoland
    125TG Therapeutics Investigational Trial SiteKrakowPoland
    126TG Therapeutics Investigational Trial SiteLublinPoland
    127TG Therapeutics Investigational Trial SiteSłupskPoland
    128TG Therapeutics Investigational Trial SiteWarszawaPoland
    129TG Therapeutics Investigational Trial SiteWroclawPoland
    130TG Therapeutics Investigational Trial SiteŁódźPoland
    131TG Therapeutics Investigational Trial SiteKrasnozatonskiyRussian Federation
    132TG Therapeutics Investigational Trial SiteMoscowRussian Federation
    133TG Therapeutics Investigational Trial SitePermRussian Federation
    134TG Therapeutics Investigational Trial SitePetrozavodskRussian Federation
    135TG Therapeutics Investigational Trial SiteRodionovaRussian Federation
    136TG Therapeutics Investigational Trial SiteSaint PetersburgRussian Federation
    137TG Therapeutics Investigational Trial SiteSmolenskRussian Federation
    138TG Therapeutics Investigational Trial SiteTulaRussian Federation
    139TG Therapeutics Investigational Trial SiteYaroslavlRussian Federation
    140TG Therapeutics Investigational Trial SiteBarcelonaSpain
    141TG Therapeutics Investigational Trial SiteMadridSpain
    142TG Therapeutics Investigational Trial SiteValenciaSpain
    143TG Therapeutics Investigational Trial SiteCambridgeUnited Kingdom
    144TG Therapeutics Investigational Trial SiteCumbriaUnited Kingdom
    145TG Therapeutics Investigational Trial SiteDudley WestUnited Kingdom
    146TG Therapeutics Investigational Trial SiteLondonUnited Kingdom
    147TG Therapeutics Investigational Trial SiteNorthbrookUnited Kingdom
    148TG Therapeutics Investigational Trial SiteNorthumbriaUnited Kingdom
    149TG Therapeutics Investigational Trial SiteNorwichUnited Kingdom
    150TG Therapeutics Investigational Trial SitePeterboroughUnited Kingdom
    151TG Therapeutics Investigational Trial SiteSouthamptonUnited Kingdom
    152TG Therapeutics Investigational Trial SiteSt. JamesUnited Kingdom
    153TG Therapeutics Investigational Trial SiteSunderlandUnited Kingdom
    154TG Therapeutics Investigational Trial SiteWolverhamptonUnited Kingdom

    Sponsors and Collaborators

    • TG Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02612311
    Other Study ID Numbers:
    • UTX-TGR-304
    First Posted:
    Nov 23, 2015
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022

    Study Results

    No Results Posted as of Jan 13, 2022