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
154
4
97.4
3.9
0

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 Disease Intervention/Treatment Phase
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

Arm Intervention/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

    Site City State Country Postal Code
    1 TG Therapeutics Investigational Trial Site Huntsville Alabama United States 35805
    2 TG Therapeutics Investigational Trial Site Mobile Alabama United States 36604
    3 TG Therapeutics Investigational Trial Site Chandler Arizona United States 85224
    4 TG Therapeutics Investigational Trial Site Phoenix Arizona United States 85016
    5 TG Therapeutics Investigational Trial Site Tucson Arizona United States 85711
    6 TG Therapeutics Investigational Trial Site Fayetteville Arkansas United States 72703
    7 TG Therapeutics Investigational Trial Site Concord California United States 94520
    8 TG Therapeutics Investigational Trial Site Duarte California United States 91010
    9 TG Therapeutics Investigational Trial Site Greenbrae California United States 94904
    10 TG Therapeutics Investigational Trial Site Pismo Beach California United States 93449
    11 TG Therapeutics Investigational Trial Site Pleasanton California United States 94588
    12 TG Therapeutics Investigational Trial Site San Diego California United States 92120
    13 TG Therapeutics Investigational Trial Site Santa Barbara California United States 93105
    14 TG Therapeutics Investigational Trial Site Whittier California United States 90603
    15 TG Therapeutics Investigational Trial Site Aurora Colorado United States 80012
    16 TG Therapeutics Investigational Trial Site Denver Colorado United States 80218
    17 TG Therapeutics Investigational Trial Site Bridgeport Connecticut United States 06606
    18 TG Therapeutics Investigational Trial Site New Haven Connecticut United States 06519
    19 TG Therapeutics Investigational Trial Site Stamford Connecticut United States 06904
    20 TG Therapeutics Investigational Trial Site Newark Delaware United States 19713
    21 TG Therapeutics Investigational Trial Site Boca Raton Florida United States 33486
    22 TG Therapeutics Investigational Trial Site Fort Myers Florida United States 33916
    23 TG Therapeutics Investigational Trial Site Jacksonville Florida United States 32204
    24 TG Therapeutics Investigational Trial Site Jacksonville Florida United States 32256
    25 TG Therapeutics Investigational Trial Site Ocala Florida United States 34471
    26 TG Therapeutics Investigational Trial Site Pensacola Florida United States 32504
    27 TG Therapeutics Investigational Trial Site Saint Petersburg Florida United States 33705
    28 TG Therapeutics Investigational Trial Site Tallahassee Florida United States 32308
    29 TG Therapeutics Investigational Trial Site Tampa Florida United States 33612
    30 TG Therapeutics Investigational Trial Site West Palm Beach Florida United States 33407
    31 TG Therapeutics Investigational Trial Site Albany Georgia United States 31701
    32 TG Therapeutics Investigational Trial Site Macon Georgia United States 31201
    33 TG Therapeutics Investigational Trial Site Chicago Illinois United States 60612
    34 TG Therapeutics Investigational Trial Site Decatur Illinois United States 62526
    35 TG Therapeutics Investigational Trial Site Maywood Illinois United States 60153
    36 TG Therapeutics Investigational Trial Site Niles Illinois United States 60714
    37 TG Therapeutics Investigational Trial Site Peoria Illinois United States 61615
    38 TG Therapeutics Investigational Trial Site Swansea Illinois United States
    39 TG Therapeutics Investigational Trial Site Urbana Illinois United States 61801
    40 TG Therapeutics Investigational Trial Site Fort Wayne Indiana United States 46804
    41 TG Therapeutics Investigational Trial Site Indianapolis Indiana United States 46237
    42 TG Therapeutics Investigational Trial Site Ames Iowa United States 50010
    43 TG Therapeutics Investigational Trial Site Cedar Rapids Iowa United States 52403
    44 TG Therapeutics Investigational Trial Site Kansas City Kansas United States 64132
    45 TG Therapeutics Investigational Trial Site Westwood Kansas United States 66210
    46 TG Therapeutics Investigational Trial Site Louisville Kentucky United States 40207
    47 TG Therapeutics Investigational Trial Site Baltimore Maryland United States 21202
    48 TG Therapeutics Investigational Trial Site Baltimore Maryland United States 21215
    49 TG Therapeutics Investigational Trial Site Bethesda Maryland United States 20817
    50 TG Therapeutics Investigational Trial Site Columbia Maryland United States 21044
    51 TG Therapeutics Investigational Trial Site Boston Massachusetts United States 02111
    52 TG Therapeutics Investigational Trial Site Worcester Massachusetts United States 01608
    53 TG Therapeutics Investigational Trial Site Ann Arbor Michigan United States 48106
    54 TG Therapeutics Investigational Trial Site Detroit Michigan United States 48202
    55 TG Therapeutics Investigational Trial Site Jackson Michigan United States 49201
    56 TG Therapeutics Investigational Trial Site Saint Louis Park Minnesota United States 55416
    57 TG Therapeutics Investigational Trial Site Columbia Missouri United States 65212
    58 TG Therapeutics Investigational Trial Site Kansas City Missouri United States
    59 TG Therapeutics Investigational Trial Site Lincoln Nebraska United States 68510
    60 TG Therapeutics Investigational Trial Site Las Vegas Nevada United States 89119
    61 TG Therapeutics Investigational Trial Site Lebanon New Hampshire United States 03756
    62 TG Therapeutics Investigational Trial Site Morristown New Jersey United States 07962
    63 TG Therapeutics Investigational Trial Site Somerville New Jersey United States 00876
    64 TG Therapeutics Investigational Trial Site East Setauket New York United States 11733
    65 TG Therapeutics Investigational Trial Site Glens Falls New York United States 12801
    66 TG Therapeutics Investigational Trial Site Syracuse New York United States 13210
    67 TG Therapeutics Investigational Trial Site Charlotte North Carolina United States 28204
    68 TG Therapeutics Investigational Trial Site Durham North Carolina United States 27710
    69 TG Therapeutics Investigational Trial Site Durham North Carolina United States
    70 TG Therapeutics Investigational Trial Site Hickory North Carolina United States 28602
    71 TG Therapeutics Investigational Trial Site Kinston North Carolina United States 28501
    72 TG Therapeutics Investigational Trial Site Raleigh North Carolina United States 27607
    73 TG Therapeutics Investigational Trial Site Washington North Carolina United States 27889
    74 TG Therapeutics Investigational Trial Site Canton Ohio United States 44718
    75 TG Therapeutics Investigational Trial Site Cincinnati Ohio United States 45236
    76 TG Therapeutics Investigational Trial Site Toledo Ohio United States 43623
    77 TG Therapeutics Investigational Trial Site Portland Oregon United States 97227
    78 TG Therapeutics Investigational Trial Site Portland Oregon United States 97239
    79 TG Therapeutics Investigational Trial Site Springfield Oregon United States 97477
    80 TG Therapeutics Investigational Trial Site Camp Hill Pennsylvania United States 17011
    81 TG Therapeutics Investigational Trial Site Danville Pennsylvania United States 17822
    82 TG Therapeutics Investigational Trial Site Hershey Pennsylvania United States 17033
    83 TG Therapeutics Investigational Trial Site Philadelphia Pennsylvania United States 19106
    84 TG Therapeutics Investigational Trial Site Pittsburgh Pennsylvania United States 15224
    85 TG Therapeutics Investigational Trial Site Pittsburgh Pennsylvania United States 15232
    86 TG Therapeutics Investigational Trial Site Pawtucket Rhode Island United States 00286
    87 TG Therapeutics Investigational Trial Site Greenville South Carolina United States 29615
    88 TG Therapeutics Investigational Trial Site Sioux Falls South Dakota United States 57105
    89 TG Therapeutics Investigational Trial Site Watertown South Dakota United States 57201
    90 TG Therapeutics Investigational Trial Site Chattanooga Tennessee United States 37404
    91 TG Therapeutics Investigational Trial Site Nashville Tennessee United States 37203
    92 TG Therapeutics Investigational Trial Site Austin Texas United States 78705
    93 TG Therapeutics Investigational Trial Site Bedford Texas United States 76022
    94 TG Therapeutics Investigational Trial Site Fort Worth Texas United States 76104
    95 TG Therapeutics Investigational Trial Site Houston Texas United States 77030
    96 TG Therapeutics Investigational Trial Site San Antonio Texas United States 78217
    97 TG Therapeutics Investigational Trial Site San Antonio Texas United States 78229
    98 TG Therapeutics Investigational Trial Site Tyler Texas United States 75702
    99 TG Therapeutics Investigational Trial Site Ogden Utah United States 84405
    100 TG Therapeutics Investigational Trial Site Blacksburg Virginia United States 24060
    101 TG Therapeutics Investigational Trial Site Charlottesville Virginia United States 22908
    102 TG Therapeutics Investigational Trial Site Fort Belvoir Virginia United States 22060
    103 TG Therapeutics Investigational Trial Site Olympia Washington United States 98502
    104 TG Therapeutics Investigational Trial Site Seattle Washington United States 98104
    105 TG Therapeutics Investigational Trial Site Seattle Washington United States 98109
    106 TG Therapeutics Investigational Trial Site Spokane Washington United States 99216
    107 TG Therapeutics Investigational Trial Site Vancouver Washington United States 98684
    108 TG Therapeutics Investigational Trial Site Yakima Washington United States 98902
    109 TG Therapeutics Investigational Trial Site Milwaukee Wisconsin United States 53226
    110 TG Therapeutics Investigational Trial Site Wauwatosa Wisconsin United States 53226
    111 TG Therapeutics Investigational Trial Site Ashkelon Israel
    112 TG Therapeutics Investigational Trial Site Be'er Sheva Israel
    113 TG Therapeutics Investigational Trial Site Haifa Israel
    114 TG Therapeutics Investigational Trial Site Jerusalem Israel
    115 TG Therapeutics Investigational Trial Site Nahariya Israel
    116 TG Therapeutics Investigational Trial Site Petah tikva Israel
    117 TG Therapeutics Investigational Trial Site Tel Aviv Israel
    118 TG Therapeutics Investigational Trial Site Bologna Italy
    119 TG Therapeutics Investigational Trial Site Ferrara Italy
    120 TG Therapeutics Investigational Trial Site Milan Italy
    121 TG Therapeutics Investigational Trial Site Rome Italy
    122 TG Therapeutics Investigational Trial Site Torino Italy
    123 TG Therapeutics Investigational Trial Site Chorzów Poland
    124 TG Therapeutics Investigational Trial Site Gdynia Poland
    125 TG Therapeutics Investigational Trial Site Krakow Poland
    126 TG Therapeutics Investigational Trial Site Lublin Poland
    127 TG Therapeutics Investigational Trial Site Słupsk Poland
    128 TG Therapeutics Investigational Trial Site Warszawa Poland
    129 TG Therapeutics Investigational Trial Site Wroclaw Poland
    130 TG Therapeutics Investigational Trial Site Łódź Poland
    131 TG Therapeutics Investigational Trial Site Krasnozatonskiy Russian Federation
    132 TG Therapeutics Investigational Trial Site Moscow Russian Federation
    133 TG Therapeutics Investigational Trial Site Perm Russian Federation
    134 TG Therapeutics Investigational Trial Site Petrozavodsk Russian Federation
    135 TG Therapeutics Investigational Trial Site Rodionova Russian Federation
    136 TG Therapeutics Investigational Trial Site Saint Petersburg Russian Federation
    137 TG Therapeutics Investigational Trial Site Smolensk Russian Federation
    138 TG Therapeutics Investigational Trial Site Tula Russian Federation
    139 TG Therapeutics Investigational Trial Site Yaroslavl Russian Federation
    140 TG Therapeutics Investigational Trial Site Barcelona Spain
    141 TG Therapeutics Investigational Trial Site Madrid Spain
    142 TG Therapeutics Investigational Trial Site Valencia Spain
    143 TG Therapeutics Investigational Trial Site Cambridge United Kingdom
    144 TG Therapeutics Investigational Trial Site Cumbria United Kingdom
    145 TG Therapeutics Investigational Trial Site Dudley West United Kingdom
    146 TG Therapeutics Investigational Trial Site London United Kingdom
    147 TG Therapeutics Investigational Trial Site Northbrook United Kingdom
    148 TG Therapeutics Investigational Trial Site Northumbria United Kingdom
    149 TG Therapeutics Investigational Trial Site Norwich United Kingdom
    150 TG Therapeutics Investigational Trial Site Peterborough United Kingdom
    151 TG Therapeutics Investigational Trial Site Southampton United Kingdom
    152 TG Therapeutics Investigational Trial Site St. James United Kingdom
    153 TG Therapeutics Investigational Trial Site Sunderland United Kingdom
    154 TG Therapeutics Investigational Trial Site Wolverhampton United 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:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022

    Study Results

    No Results Posted as of Aug 22, 2022