An Open-Label Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02656303
Collaborator
(none)
300
Enrollment
87
Locations
1
Arm
109.8
Anticipated Duration (Months)
3.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center, open-label, study to evaluate the safety and efficacy of ublituximab (TG-1101) in combination with TGR-1202 for patients who have progressed on treatment arms previously enrolled in Protocol UTX-TGR-304

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Open-Label, Study to Evaluate the Safety and Efficacy of Ublituximab (TG-1101) in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304
Actual Study Start Date :
Jan 7, 2016
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: Ublituximab + TGR-1202

Ublituximab IV treatment + TGR-1202 oral daily dose

Biological: ublituximab
ublituximab IV infusion
Other Names:
  • TG-1101
  • Drug: TGR-1202
    TGR-1202 oral daily dose

    Outcome Measures

    Primary 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Prior treatment in clinical trial UTX-TGR-304

    • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

    Exclusion Criteria:
    • Patients refractory to ublituximab + TGR-1202

    • Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1TG Therapeutics Investigational Trial SiteHuntsvilleAlabamaUnited States35805
    2TG Therapeutics Investigational Trial SiteChandlerArizonaUnited States85224
    3TG Therapeutics Investigational Trial SiteFayettevilleArkansasUnited States72703
    4TG Therapeutics Investigational Trial SiteDuarteCaliforniaUnited States91010
    5TG Therapeutics Investigational Trial SitePleasantonCaliforniaUnited States94588
    6TG Therapeutics Investigational Trial SiteSan DiegoCaliforniaUnited States92108
    7TG Therapeutics Investigational Trial SiteWhittierCaliforniaUnited States90603
    8TG Therapeutics Investigational Trial SiteAuroraColoradoUnited States80012
    9TG Therapeutics Investigational Trial SiteDenverColoradoUnited States80218
    10TG Therapeutics Investigational Trial SiteBridgeportConnecticutUnited States06606
    11TG Therapeutics Investigational Trial SiteNew HavenConnecticutUnited States06519
    12TG Therapeutics Investigational Trial SiteStamfordConnecticutUnited States06904
    13TG Therapeutics Investigational Trial SiteNewarkDelawareUnited States19713
    14TG Therapeutics Investigational Trial SiteBoca RatonFloridaUnited States33486
    15TG Therapeutics Investigational Trial SiteFort MyersFloridaUnited States33916
    16TG Therapeutics Investigational Trial SiteJacksonvilleFloridaUnited States32204
    17TG Therapeutics Investigational Trial SiteJacksonvilleFloridaUnited States32256
    18TG Therapeutics Investigational Trial SiteSaint PetersburgFloridaUnited States33705
    19TG Therapeutics Investigational Trial SiteTallahasseeFloridaUnited States32308
    20TG Therapeutics Investigational Trial SiteWest Palm BeachFloridaUnited States33401
    21TG Therapeutics Investigational Trial SiteAlbanyGeorgiaUnited States31701
    22TG Therapeutics Investigational Trial SiteChicagoIllinoisUnited States60612
    23TG Therapeutics Investigational Trial SitePeoriaIllinoisUnited States61615
    24TG Therapeutics Investigational Trial SiteSwanseaIllinoisUnited States62526
    25TG Therapeutics Investigational Trial SiteUrbanaIllinoisUnited States61801
    26TG Therapeutics Investigational Trial SiteFort WayneIndianaUnited States46804
    27TG Therapeutics Investigational Trial SiteIndianapolisIndianaUnited States46237
    28TG Therapeutics Investigational Trial SiteWestwoodKansasUnited States66210
    29TG Therapeutics Investigational Trial SiteLouisvilleKentuckyUnited States40207
    30TG Therapeutics Investigational Trial SiteWorcesterMassachusettsUnited States01608
    31TG Therapeutics Investigational Trial SiteAnn ArborMichiganUnited States48197
    32TG Therapeutics Investigational Trial SiteDetroitMichiganUnited States48202
    33TG Therapeutics Investigational Trial SiteJacksonMichiganUnited States49201
    34TG Therapeutics Investigational Trial SiteSaint Louis ParkMinnesotaUnited States55416
    35TG Therapeutics Investigational Trial SiteKansas CityMissouriUnited States64132
    36TG Therapeutics Investigational Trial SiteLincolnNebraskaUnited States68510
    37TG Therapeutics Investigational Trial SiteLebanonNew HampshireUnited States03756
    38TG Therapeutics Investigational Trial SiteMorristownNew JerseyUnited States07932
    39TG Therapeutics Investigational Trial SiteGlens FallsNew YorkUnited States12801
    40TG Therapeutics Investigational Trial SiteSyracuseNew YorkUnited States13210
    41TG Therapeutics Investigational Trial SiteCharlotteNorth CarolinaUnited States28204
    42TG Therapeutics Investigational Trial SiteDurhamNorth CarolinaUnited States27705
    43TG Therapeutics Investigational Trial SiteDurhamNorth CarolinaUnited States27710
    44TG Therapeutics Investigational Trial SiteHickoryNorth CarolinaUnited States28602
    45TG Therapeutics Investigational Trial SiteKinstonNorth CarolinaUnited States28501
    46TG Therapeutics Investigational Trial SiteWashingtonNorth CarolinaUnited States27889
    47TG Therapeutics Investigational Trial SiteCantonOhioUnited States44718
    48TG Therapeutics Investigational Trial SiteToledoOhioUnited States43623
    49TG Therapeutics Investigational Trial SitePortlandOregonUnited States97227
    50TG Therapeutics Investigational Trial SitePortlandOregonUnited States98684
    51TG Therapeutics Investigational Trial SiteSpringfieldOregonUnited States97477
    52TG Therapeutics Investigational Trial SiteCamp HillPennsylvaniaUnited States17011
    53TG Therapeutics Investigational Trial SiteHersheyPennsylvaniaUnited States17033
    54TG Therapeutics Investigational Trial SitePhiladelphiaPennsylvaniaUnited States19106
    55TG Therapeutics Investigational Trial SitePittsburghPennsylvaniaUnited States15224
    56TG Therapeutics Investigational Trial SitePawtucketRhode IslandUnited States02860
    57TG Therapeutics Investigational Trial SiteGreenvilleSouth CarolinaUnited States29605
    58TG Therapeutics Investigational Trial SiteSioux FallsSouth DakotaUnited States57105
    59TG Therapeutics Investigational Trial SiteChattanoogaTennesseeUnited States37404
    60TG Therapeutics Investigational Trial SiteNashvilleTennesseeUnited States37203
    61TG Therapeutics Investigational Trial SiteFort WorthTexasUnited States76104
    62TG Therapeutics Investigational Trial SiteSan AntonioTexasUnited States78240
    63TG Therapeutics Investigational Trial SiteOgdenUtahUnited States84405
    64TG Therapeutics Investigational Trial SiteBlacksburgVirginiaUnited States24060
    65TG Therapeutics Investigational Trial SiteCharlottesvilleVirginiaUnited States22908
    66TG Therapeutics Investigational Trial SiteFort BelvoirVirginiaUnited States22060
    67TG Therapeutics Investigational Trial SiteSeattleWashingtonUnited States98109
    68TG Therapeutics Investigational Trial SiteSpokaneWashingtonUnited States99216
    69TG Therapeutics Investigational Trial SiteWauwatosaWisconsinUnited States53226
    70TG Therapeutics Investigational Trial SiteFerraraItaly44020
    71TG Therapeutics Investigational Trial SiteMilanItaly20132
    72TG Therapeutics Investigational Trial SiteMilanItaly20141
    73TG Therapeutics Investigational Trial SiteTorinoItaly10126
    74TG Therapeutics Investigational Trial SiteChorzówPoland41-500
    75TG Therapeutics Investigational Trial SiteGdyniaPoland81-519
    76TG Therapeutics Investigational Trial SiteKrakówPoland30-510
    77TG Therapeutics Investigational Trial SiteLublinPoland20-090
    78TG Therapeutics Investigational Trial SiteSłupskPoland76-200
    79TG Therapeutics Investigational Trial SiteWarszawaPoland02-106
    80TG Therapeutics Investigational Trial SiteWarszawaPoland02-776
    81TG Therapeutics Investigational Trial SiteWarszawaPoland02-781
    82TG Therapeutics Investigational Trial SiteWarszawaPoland50-367
    83TG Therapeutics Investigational Trial SiteŁódźPoland93-513
    84TG Therapeutics Investigational Trial SiteLondonUnited KingdomSW170QT
    85TG Therapeutics Investigational Trial SiteNorwichUnited KingdomNR47UY
    86TG Therapeutics Investigational Trial SiteSunderlandUnited KingdomSR47TP
    87TG Therapeutics Investigational Trial SiteWolverhamptonUnited KingdomWV100QP

    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:
    NCT02656303
    Other Study ID Numbers:
    • UTX-TGR-204
    First Posted:
    Jan 14, 2016
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 13, 2022