UNITY-NHL: Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02793583
Collaborator
(none)
900
Enrollment
168
Locations
3
Arms
109.2
Anticipated Duration (Months)
5.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Unity NHL - A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib with or without Bendamustine and Umbralisib alone in Patients with Previously Treated Non-Hodgkin's Lymphoma

Condition or DiseaseIntervention/TreatmentPhase
Phase 2/Phase 3

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of umbralisib monotherapy and the umbralisib + ublituximab (U2) combination in aggressive and indolent lymphomas and to also explore the U2 regimen in combination with bendamustine in the treatment of NHL (FL, SLL, MZL, DLBCL and MCL).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma
Actual Study Start Date :
May 25, 2016
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: Umbralisib + Ublituximab

Umbralisib oral daily dose in combination with Ublituximab intravenous administration

Biological: Ublituximab
Other Names:
  • TG-1101
  • Drug: Umbralisib
    Other Names:
  • TGR-1202
  • Experimental: Umbralisib

    Umbralisib oral daily dose

    Drug: Umbralisib
    Other Names:
  • TGR-1202
  • Experimental: Umbralisib + Ublituximab + Bendamustine

    Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration

    Biological: Ublituximab
    Other Names:
  • TG-1101
  • Drug: Umbralisib
    Other Names:
  • TGR-1202
  • Biological: Bendamustine
    Other Names:
  • Treanda
  • Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of Non-Hodgkin's Lymphoma including Follicular, Mantle Cell Lymphoma and Marginal Zone Lymphoma

    • Relapsed or refractory to prior standard therapy and subjects who are not candidates for high-dose therapy or autologous stem cell transplant

    • MCL subjects with one or more lines of therapy including at least one BTK inhibitor (ibrutinib, acalabrutinib or zanibrutinib only)

    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 6 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded

    • Prior therapy with a PI3K delta inhibitor

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1TG Therapeutics Investigational Trial SiteBirminghamAlabamaUnited States35243
    2TG Therapeutics Investigational Trial SiteHuntsvilleAlabamaUnited States35805
    3TG Therapeutics Investigational Trial SiteChandlerArizonaUnited States85224
    4TG Therapeutics Investigational Trial SiteTucsonArizonaUnited States85711
    5TG Therapeutics Investigational Trial SiteTucsonArizonaUnited States85724
    6TG Therapeutics Investigational Trial SiteLos AngelesCaliforniaUnited States90095
    7TG Therapeutics Investigational Trial SiteOrangeCaliforniaUnited States92868
    8TG Therapeutics Investigational Trial SiteSan DiegoCaliforniaUnited States90710
    9TG Therapeutics Investigational Trial SiteSan DiegoCaliforniaUnited States92108
    10TG Therapeutics Investigational Trial SiteWhittierCaliforniaUnited States90603
    11TG Therapeutics Investigational Trial SiteAuroraColoradoUnited States80012
    12TG Therapeutics Investigational Trial SiteDenverColoradoUnited States80218
    13TG Therapeutics Investigational Trial SiteFort CollinsColoradoUnited States80528
    14TG Therapeutics Investigational Trial SiteBridgeportConnecticutUnited States06606
    15TG Therapeutics Investigational Trial SiteNewarkDelawareUnited States19713
    16TG Therapeutics Investigational Trial SiteWashingtonDistrict of ColumbiaUnited States20007
    17TG Therapeutics Investigational Trial SiteBoca RatonFloridaUnited States33486
    18TG Therapeutics Investigational Trial SiteFort MyersFloridaUnited States33916
    19TG Therapeutics Investigational Trial SiteGainesvilleFloridaUnited States32608
    20TG Therapeutics Investigational Trial SiteJacksonvilleFloridaUnited States32204
    21TG Therapeutics Investigational Trial SiteJacksonvilleFloridaUnited States32224
    22TG Therapeutics Investigational Trial SiteJacksonvilleFloridaUnited States32256
    23TG Therapeutics Investigational Trial SiteMiamiFloridaUnited States33176
    24TG Therapeutics Investigational Trial SiteSaint PetersburgFloridaUnited States33705
    25TG Therapeutics Investigational Trial SiteTallahasseeFloridaUnited States32308
    26TG Therapeutics Investigational Trial SiteTampaFloridaUnited States33612
    27TG Therapeutics Investigational Trial SiteWest Palm BeachFloridaUnited States33407
    28TG Therapeutics Investigational Trial SiteAlbanyGeorgiaUnited States31701
    29TG Therapeutics Investigational Trial SiteMaconGeorgiaUnited States31201
    30TG Therapeutics Investigational Trial SiteMariettaGeorgiaUnited States30060
    31TG Therapeutics Investigational Trial SiteChicagoIllinoisUnited States60612
    32TG Therapeutics Investigational Trial SiteChicagoIllinoisUnited States60637
    33TG Therapeutics Investigational Trial SiteDecaturIllinoisUnited States62526
    34TG Therapeutics Investigational Trial SiteEvanstonIllinoisUnited States60201
    35TG Therapeutics Investigational Trial SiteHarveyIllinoisUnited States60426
    36TG Therapeutics Investigational Trial SiteMaywoodIllinoisUnited States60153
    37TG Therapeutics Investigational Trial SiteNilesIllinoisUnited States60714
    38TG Therapeutics Investigational Trial SitePeoriaIllinoisUnited States61615
    39TG Therapeutics Investigational Trial SiteSwanseaIllinoisUnited States62226
    40TG Therapeutics Investigational Trial SiteFort WayneIndianaUnited States46845
    41TG Therapeutics Investigational Trial SiteIndianapolisIndianaUnited States46237
    42TG Therapeutics Investigational Trial SiteWestwoodKansasUnited States66210
    43TG Therapeutics Investigational Trial SiteLouisvilleKentuckyUnited States40207
    44TG Therapeutics Investigational Trial SiteCovingtonLouisianaUnited States70433
    45TG Therapeutics Investigational Trial SiteBrewerMaineUnited States04412
    46TG Therapeutics Investigational Trial SiteBaltimoreMarylandUnited States21201
    47TG Therapeutics Investigational Trial SiteBethesdaMarylandUnited States20817
    48TG Therapeutics Investigational Trial SiteColumbiaMarylandUnited States21044
    49TG Therapeutics Investigational Trial SiteTowsonMarylandUnited States21204
    50TG Therapeutics Investigational Trial SiteAnn ArborMichiganUnited States48109
    51TG Therapeutics Investigational Trial SiteDuluthMinnesotaUnited States55805
    52TG Therapeutics Investigational Trial SiteSaint Louis ParkMinnesotaUnited States55416
    53TG Therapeutics Investigational Trial SiteColumbiaMissouriUnited States65212
    54TG Therapeutics Investigational Trial SiteKansas CityMissouriUnited States64132
    55TG Therapeutics Investigational Trial SiteSaint LouisMissouriUnited States63110
    56TG Therapeutics Investigational Trial SiteBillingsMontanaUnited States59102
    57TG Therapeutics Investigational Trial SiteLincolnNebraskaUnited States68510
    58TG Therapeutics Investigational Trial SiteOmahaNebraskaUnited States68130
    59TG Therapeutics Investigational Trial SiteLebanonNew HampshireUnited States03756
    60TG Therapeutics Investigational Trial SiteHackensackNew JerseyUnited States07601
    61TG Therapeutics Investigational Trial SiteMorristownNew JerseyUnited States07962
    62TG Therapeutics Investigational Trial SiteMount HollyNew JerseyUnited States08060
    63TG Therapeutics Investigational Trial SiteFarmingtonNew MexicoUnited States87401
    64TG Therapeutics Investigational Trial SiteBronxNew YorkUnited States10467
    65TG Therapeutics Investigational Trial SiteBuffaloNew YorkUnited States14263
    66TG Therapeutics Investigational Trial SiteNew YorkNew YorkUnited States10019
    67TG Therapeutics Investigational Trial SiteSyracuseNew YorkUnited States13210
    68TG Therapeutics Investigational Trial SiteCharlotteNorth CarolinaUnited States28201
    69TG Therapeutics Investigational Trial SiteDurhamNorth CarolinaUnited States27705
    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 States45220
    76TG Therapeutics Investigational Trial SiteCincinnatiOhioUnited States45242
    77TG Therapeutics Investigational Trial SiteClevelandOhioUnited States44106
    78TG Therapeutics Investigational Trial SiteColumbusOhioUnited States43219
    79TG Therapeutics Investigational Trial SiteToledoOhioUnited States43623
    80TG Therapeutics Investigational Trial SitePortlandOregonUnited States97213
    81TG Therapeutics Investigational Trial SitePortlandOregonUnited States97227
    82TG Therapeutics Investigational Trial SiteSpringfieldOregonUnited States97477
    83TG Therapeutics Investigational Trial SiteCamp HillPennsylvaniaUnited States17011
    84TG Therapeutics Investigational Trial SitePhiladelphiaPennsylvaniaUnited States19106
    85TG Therapeutics Investigational Trial SiteProvidenceRhode IslandUnited States02906
    86TG Therapeutics Investigational Trial SiteGreenvilleSouth CarolinaUnited States29615
    87TG Therapeutics Investigational Trial SiteSioux FallsSouth DakotaUnited States57105
    88TG Therapeutics Investigational Trial SiteWatertownSouth DakotaUnited States57201
    89TG Therapeutics Investigational Trial SiteChattanoogaTennesseeUnited States37404
    90TG Therapeutics Investigational Trial SiteKingsportTennesseeUnited States37660
    91TG Therapeutics Investigational Trial SiteKnoxvilleTennesseeUnited States37916
    92TG Therapeutics Investigational Trial SiteMemphisTennesseeUnited States38120
    93TG Therapeutics Investigational Trial SiteAustinTexasUnited States78705
    94TG Therapeutics Investigational Trial SiteDallasTexasUnited States75390
    95TG Therapeutics Investigational Trial SiteFort Sam HoustonTexasUnited States78234
    96TG Therapeutics Investigational Trial SiteHoustonTexasUnited States77030
    97TG Therapeutics Investigational Trial SiteSan AntonioTexasUnited States78130
    98TG Therapeutics Investigational Trial SiteSan AntonioTexasUnited States78217
    99TG Therapeutics Investigational Trial SiteSan AntonioTexasUnited States78229
    100TG Therapeutics Investigational Trial SiteTylerTexasUnited States75702
    101TG Therapeutics Investigational Trial SiteOgdenUtahUnited States84403
    102TG Therapeutics Investigational Trial SiteBlacksburgVirginiaUnited States24060
    103TG Therapeutics Investigational Trial SiteNewport NewsVirginiaUnited States23601
    104TG Therapeutics Investigational Trial SiteOlympiaWashingtonUnited States98502
    105TG Therapeutics Investigational Trial SiteSeattleWashingtonUnited States98104
    106TG Therapeutics Investigational Trial SiteSeattleWashingtonUnited States98108
    107TG Therapeutics Investigational Trial SiteSeattleWashingtonUnited States98109
    108TG Therapeutics Investigational Trial SiteSpokaneWashingtonUnited States99216
    109TG Therapeutics Investigational Trial SiteVancouverWashingtonUnited States97277
    110TG Therapeutics Investigational Trial SiteMadisonWisconsinUnited States53792
    111TG Therapeutics Investigational Trial SiteWauwatosaWisconsinUnited States53226
    112TG Therapeutics Investigational Trial SiteGosfordNew South WalesAustralia02250
    113TG Therapeutics Investigational Trial SiteWahroongaNew South WalesAustralia02076
    114TG Therapeutics Investigational Trial SiteBenowaQueenslandAustralia04217
    115TG Therapeutics Investigational Trial SiteSouth BrisbaneQueenslandAustralia04101
    116TG Therapeutics Investigational Trial SiteAdelaideSouth AustraliaAustralia05000
    117TG Therapeutics Investigational Trial SiteHeidelbergVictoriaAustralia03084
    118TG Therapeutics Investigational Trial SiteNedlandsWestern AustraliaAustralia06009
    119TG Therapeutics Investigational Trial SiteNetherlandsWestern AustraliaAustralia06009
    120TG Therapeutics Investigational Trial SiteGosfordAustralia2076
    121TG Therapeutics Investigational Trial SiteAshkelonIsrael7830604
    122TG Therapeutics Investigational Trial SiteBe'er ShevaIsrael8410101
    123TG Therapeutics Investigational Trial SiteHaifaIsrael91031
    124TG Therapeutics Investigational Trial SiteJerusalemIsrael9112001
    125TG Therapeutics Investigational Trial SiteNahariyaIsrael2210001
    126TG Therapeutics Investigational Trial SitePetah TikvaIsrael49100
    127TG Therapeutics Investigational Trial SiteTel AvivIsrael64239
    128TG Therapeutics Investigational Trial SiteTel AvivIsrael6971028
    129TG Therapeutics Investigational Trial SiteBolognaItaly40138
    130TG Therapeutics Investigational Trial SiteFerraraItaly44020
    131TG Therapeutics Investigational Trial SiteMilanItaly20132
    132TG Therapeutics Investigational Trial SiteMilanItaly20141
    133TG Therapeutics Investigational Trial SiteRomeItaly00161
    134TG Therapeutics Investigational Trial SiteTorinoItaly10126
    135TG Therapeutics Investigational Trial SiteBusanKorea, Republic of47392
    136TG Therapeutics Investigational Trial SiteBusanKorea, Republic of49241
    137TG Therapeutics Investigational Trial SiteGyeonggi-doKorea, Republic of13620
    138TG Therapeutics Investigational Trial SiteIncheonKorea, Republic of21565
    139TG Therapeutics Investigational Trial SiteSeoulKorea, Republic of03080
    140TG Therapeutics Investigational Trial SiteSeoulKorea, Republic of06351
    141TG Therapeutics Investigational Trial SiteSeoulKorea, Republic of06591
    142TG Therapeutics Investigational Trial SiteChorzówPoland41-500
    143TG Therapeutics Investigational Trial SiteGdyniaPoland81-519
    144TG Therapeutics Investigational Trial SiteKrakówPoland30-510
    145TG Therapeutics Investigational Trial SiteLublinPoland20-090
    146TG Therapeutics Investigational Trial SiteSłupskPoland76-200
    147TG Therapeutics Investigational Trial SiteWarszawaPoland02-106
    148TG Therapeutics Investigational Trial SiteWarszawaPoland02-781
    149TG Therapeutics Investigational Trial SiteWrocławPoland50-367
    150TG Therapeutics Investigational Trial SiteŁódźPoland93-513
    151TG Therapeutics Investigational Trial SiteBratislavaSlovakia81250
    152TG Therapeutics Investigational Trial SiteBratislavaSlovakia83310
    153TG Therapeutics Investigational Trial SiteKošiceSlovakia04191
    154TG Therapeutics Investigational Trial SitePopradSlovakia05801
    155TG Therapeutics Investigational Trial SiteBarcelonaSpain08035
    156TG Therapeutics Investigational Trial SiteBarcelonaSpain08041
    157TG Therapeutics Investigational Trial SiteMadridSpain28041
    158TG Therapeutics Investigational Trial SiteMadridSpain28222
    159TG Therapeutics Investigational Trial SiteSalisburySpain37007
    160TG Therapeutics Investigational Trial SiteValenciaSpain46010
    161TG Therapeutics Investigational Trial SiteCambridgeUnited KingdomCB2-0QQ
    162TG Therapeutics Investigational Trial SiteDenmark HillUnited KingdomSE5-9RS
    163TG Therapeutics Investigational Trial SiteLeedsUnited KingdomLS97TF
    164TG Therapeutics Investigational Trial SiteLiverpoolUnited KingdomL7-8XP
    165TG Therapeutics Investigational Trial SiteLondonUnited KingdomEC1A-7BE
    166TG Therapeutics Investigational Trial SiteLondonUnited KingdomSW170QT
    167TG Therapeutics Investigational Trial SiteOxfordUnited KingdomOX37LE
    168TG Therapeutics Investigational Trial SitePlymouthUnited KingdomPL68DH

    Sponsors and Collaborators

    • TG Therapeutics, Inc.

    Investigators

    • Study Chair: Owen A O'Connor, MD, PhD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02793583
    Other Study ID Numbers:
    • UTX-TGR-205
    First Posted:
    Jun 8, 2016
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by TG Therapeutics, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 23, 2022