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
Terminated
CT.gov ID
NCT02793583
Collaborator
(none)
710
168
3
73.3
4.2
0.1
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Actual Enrollment
:
710 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
Actual Primary Completion Date
:
May 31, 2022
Actual Study Completion Date
:
Jul 4, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Umbralisib + Ublituximab Umbralisib oral daily dose in combination with Ublituximab intravenous administration |
Biological: Ublituximab
Other Names:
Drug: Umbralisib
Other Names:
|
| Experimental: Umbralisib Umbralisib oral daily dose |
Drug: Umbralisib
Other Names:
|
| Experimental: Umbralisib + Ublituximab + Bendamustine Umbralisib oral daily dose in combination with Ublituximab intravenous administration and Bendamustine intravenous administration |
Biological: Ublituximab
Other Names:
Drug: Umbralisib
Other Names:
Biological: Bendamustine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate [Every 8-12 weeks, up to 2 years]
Secondary Outcome Measures
- 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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | TG Therapeutics Investigational Trial Site | Birmingham | Alabama | United States | 35243 |
| 2 | TG Therapeutics Investigational Trial Site | Huntsville | Alabama | United States | 35805 |
| 3 | TG Therapeutics Investigational Trial Site | Chandler | Arizona | United States | 85224 |
| 4 | TG Therapeutics Investigational Trial Site | Tucson | Arizona | United States | 85711 |
| 5 | TG Therapeutics Investigational Trial Site | Tucson | Arizona | United States | 85724 |
| 6 | TG Therapeutics Investigational Trial Site | Los Angeles | California | United States | 90095 |
| 7 | TG Therapeutics Investigational Trial Site | Orange | California | United States | 92868 |
| 8 | TG Therapeutics Investigational Trial Site | San Diego | California | United States | 90710 |
| 9 | TG Therapeutics Investigational Trial Site | San Diego | California | United States | 92108 |
| 10 | TG Therapeutics Investigational Trial Site | Whittier | California | United States | 90603 |
| 11 | TG Therapeutics Investigational Trial Site | Aurora | Colorado | United States | 80012 |
| 12 | TG Therapeutics Investigational Trial Site | Denver | Colorado | United States | 80218 |
| 13 | TG Therapeutics Investigational Trial Site | Fort Collins | Colorado | United States | 80528 |
| 14 | TG Therapeutics Investigational Trial Site | Bridgeport | Connecticut | United States | 06606 |
| 15 | TG Therapeutics Investigational Trial Site | Newark | Delaware | United States | 19713 |
| 16 | TG Therapeutics Investigational Trial Site | Washington | District of Columbia | United States | 20007 |
| 17 | TG Therapeutics Investigational Trial Site | Boca Raton | Florida | United States | 33486 |
| 18 | TG Therapeutics Investigational Trial Site | Fort Myers | Florida | United States | 33916 |
| 19 | TG Therapeutics Investigational Trial Site | Gainesville | Florida | United States | 32608 |
| 20 | TG Therapeutics Investigational Trial Site | Jacksonville | Florida | United States | 32204 |
| 21 | TG Therapeutics Investigational Trial Site | Jacksonville | Florida | United States | 32224 |
| 22 | TG Therapeutics Investigational Trial Site | Jacksonville | Florida | United States | 32256 |
| 23 | TG Therapeutics Investigational Trial Site | Miami | Florida | United States | 33176 |
| 24 | TG Therapeutics Investigational Trial Site | Saint Petersburg | Florida | United States | 33705 |
| 25 | TG Therapeutics Investigational Trial Site | Tallahassee | Florida | United States | 32308 |
| 26 | TG Therapeutics Investigational Trial Site | Tampa | Florida | United States | 33612 |
| 27 | TG Therapeutics Investigational Trial Site | West Palm Beach | Florida | United States | 33407 |
| 28 | TG Therapeutics Investigational Trial Site | Albany | Georgia | United States | 31701 |
| 29 | TG Therapeutics Investigational Trial Site | Macon | Georgia | United States | 31201 |
| 30 | TG Therapeutics Investigational Trial Site | Marietta | Georgia | United States | 30060 |
| 31 | TG Therapeutics Investigational Trial Site | Chicago | Illinois | United States | 60612 |
| 32 | TG Therapeutics Investigational Trial Site | Chicago | Illinois | United States | 60637 |
| 33 | TG Therapeutics Investigational Trial Site | Decatur | Illinois | United States | 62526 |
| 34 | TG Therapeutics Investigational Trial Site | Evanston | Illinois | United States | 60201 |
| 35 | TG Therapeutics Investigational Trial Site | Harvey | Illinois | United States | 60426 |
| 36 | TG Therapeutics Investigational Trial Site | Maywood | Illinois | United States | 60153 |
| 37 | TG Therapeutics Investigational Trial Site | Niles | Illinois | United States | 60714 |
| 38 | TG Therapeutics Investigational Trial Site | Peoria | Illinois | United States | 61615 |
| 39 | TG Therapeutics Investigational Trial Site | Swansea | Illinois | United States | 62226 |
| 40 | TG Therapeutics Investigational Trial Site | Fort Wayne | Indiana | United States | 46845 |
| 41 | TG Therapeutics Investigational Trial Site | Indianapolis | Indiana | United States | 46237 |
| 42 | TG Therapeutics Investigational Trial Site | Westwood | Kansas | United States | 66210 |
| 43 | TG Therapeutics Investigational Trial Site | Louisville | Kentucky | United States | 40207 |
| 44 | TG Therapeutics Investigational Trial Site | Covington | Louisiana | United States | 70433 |
| 45 | TG Therapeutics Investigational Trial Site | Brewer | Maine | United States | 04412 |
| 46 | TG Therapeutics Investigational Trial Site | Baltimore | Maryland | United States | 21201 |
| 47 | TG Therapeutics Investigational Trial Site | Bethesda | Maryland | United States | 20817 |
| 48 | TG Therapeutics Investigational Trial Site | Columbia | Maryland | United States | 21044 |
| 49 | TG Therapeutics Investigational Trial Site | Towson | Maryland | United States | 21204 |
| 50 | TG Therapeutics Investigational Trial Site | Ann Arbor | Michigan | United States | 48109 |
| 51 | TG Therapeutics Investigational Trial Site | Duluth | Minnesota | United States | 55805 |
| 52 | TG Therapeutics Investigational Trial Site | Saint Louis Park | Minnesota | United States | 55416 |
| 53 | TG Therapeutics Investigational Trial Site | Columbia | Missouri | United States | 65212 |
| 54 | TG Therapeutics Investigational Trial Site | Kansas City | Missouri | United States | 64132 |
| 55 | TG Therapeutics Investigational Trial Site | Saint Louis | Missouri | United States | 63110 |
| 56 | TG Therapeutics Investigational Trial Site | Billings | Montana | United States | 59102 |
| 57 | TG Therapeutics Investigational Trial Site | Lincoln | Nebraska | United States | 68510 |
| 58 | TG Therapeutics Investigational Trial Site | Omaha | Nebraska | United States | 68130 |
| 59 | TG Therapeutics Investigational Trial Site | Lebanon | New Hampshire | United States | 03756 |
| 60 | TG Therapeutics Investigational Trial Site | Hackensack | New Jersey | United States | 07601 |
| 61 | TG Therapeutics Investigational Trial Site | Morristown | New Jersey | United States | 07962 |
| 62 | TG Therapeutics Investigational Trial Site | Mount Holly | New Jersey | United States | 08060 |
| 63 | TG Therapeutics Investigational Trial Site | Farmington | New Mexico | United States | 87401 |
| 64 | TG Therapeutics Investigational Trial Site | Bronx | New York | United States | 10467 |
| 65 | TG Therapeutics Investigational Trial Site | Buffalo | New York | United States | 14263 |
| 66 | TG Therapeutics Investigational Trial Site | New York | New York | United States | 10019 |
| 67 | TG Therapeutics Investigational Trial Site | Syracuse | New York | United States | 13210 |
| 68 | TG Therapeutics Investigational Trial Site | Charlotte | North Carolina | United States | 28201 |
| 69 | TG Therapeutics Investigational Trial Site | Durham | North Carolina | United States | 27705 |
| 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 | 45220 |
| 76 | TG Therapeutics Investigational Trial Site | Cincinnati | Ohio | United States | 45242 |
| 77 | TG Therapeutics Investigational Trial Site | Cleveland | Ohio | United States | 44106 |
| 78 | TG Therapeutics Investigational Trial Site | Columbus | Ohio | United States | 43219 |
| 79 | TG Therapeutics Investigational Trial Site | Toledo | Ohio | United States | 43623 |
| 80 | TG Therapeutics Investigational Trial Site | Portland | Oregon | United States | 97213 |
| 81 | TG Therapeutics Investigational Trial Site | Portland | Oregon | United States | 97227 |
| 82 | TG Therapeutics Investigational Trial Site | Springfield | Oregon | United States | 97477 |
| 83 | TG Therapeutics Investigational Trial Site | Camp Hill | Pennsylvania | United States | 17011 |
| 84 | TG Therapeutics Investigational Trial Site | Philadelphia | Pennsylvania | United States | 19106 |
| 85 | TG Therapeutics Investigational Trial Site | Providence | Rhode Island | United States | 02906 |
| 86 | TG Therapeutics Investigational Trial Site | Greenville | South Carolina | United States | 29615 |
| 87 | TG Therapeutics Investigational Trial Site | Sioux Falls | South Dakota | United States | 57105 |
| 88 | TG Therapeutics Investigational Trial Site | Watertown | South Dakota | United States | 57201 |
| 89 | TG Therapeutics Investigational Trial Site | Chattanooga | Tennessee | United States | 37404 |
| 90 | TG Therapeutics Investigational Trial Site | Kingsport | Tennessee | United States | 37660 |
| 91 | TG Therapeutics Investigational Trial Site | Knoxville | Tennessee | United States | 37916 |
| 92 | TG Therapeutics Investigational Trial Site | Memphis | Tennessee | United States | 38120 |
| 93 | TG Therapeutics Investigational Trial Site | Austin | Texas | United States | 78705 |
| 94 | TG Therapeutics Investigational Trial Site | Dallas | Texas | United States | 75390 |
| 95 | TG Therapeutics Investigational Trial Site | Fort Sam Houston | Texas | United States | 78234 |
| 96 | TG Therapeutics Investigational Trial Site | Houston | Texas | United States | 77030 |
| 97 | TG Therapeutics Investigational Trial Site | San Antonio | Texas | United States | 78130 |
| 98 | TG Therapeutics Investigational Trial Site | San Antonio | Texas | United States | 78217 |
| 99 | TG Therapeutics Investigational Trial Site | San Antonio | Texas | United States | 78229 |
| 100 | TG Therapeutics Investigational Trial Site | Tyler | Texas | United States | 75702 |
| 101 | TG Therapeutics Investigational Trial Site | Ogden | Utah | United States | 84403 |
| 102 | TG Therapeutics Investigational Trial Site | Blacksburg | Virginia | United States | 24060 |
| 103 | TG Therapeutics Investigational Trial Site | Newport News | Virginia | United States | 23601 |
| 104 | TG Therapeutics Investigational Trial Site | Olympia | Washington | United States | 98502 |
| 105 | TG Therapeutics Investigational Trial Site | Seattle | Washington | United States | 98104 |
| 106 | TG Therapeutics Investigational Trial Site | Seattle | Washington | United States | 98108 |
| 107 | TG Therapeutics Investigational Trial Site | Seattle | Washington | United States | 98109 |
| 108 | TG Therapeutics Investigational Trial Site | Spokane | Washington | United States | 99216 |
| 109 | TG Therapeutics Investigational Trial Site | Vancouver | Washington | United States | 97277 |
| 110 | TG Therapeutics Investigational Trial Site | Madison | Wisconsin | United States | 53792 |
| 111 | TG Therapeutics Investigational Trial Site | Wauwatosa | Wisconsin | United States | 53226 |
| 112 | TG Therapeutics Investigational Trial Site | Gosford | New South Wales | Australia | 02250 |
| 113 | TG Therapeutics Investigational Trial Site | Wahroonga | New South Wales | Australia | 02076 |
| 114 | TG Therapeutics Investigational Trial Site | Benowa | Queensland | Australia | 04217 |
| 115 | TG Therapeutics Investigational Trial Site | South Brisbane | Queensland | Australia | 04101 |
| 116 | TG Therapeutics Investigational Trial Site | Adelaide | South Australia | Australia | 05000 |
| 117 | TG Therapeutics Investigational Trial Site | Heidelberg | Victoria | Australia | 03084 |
| 118 | TG Therapeutics Investigational Trial Site | Nedlands | Western Australia | Australia | 06009 |
| 119 | TG Therapeutics Investigational Trial Site | Netherlands | Western Australia | Australia | 06009 |
| 120 | TG Therapeutics Investigational Trial Site | Gosford | Australia | 2076 | |
| 121 | TG Therapeutics Investigational Trial Site | Ashkelon | Israel | 7830604 | |
| 122 | TG Therapeutics Investigational Trial Site | Be'er Sheva | Israel | 8410101 | |
| 123 | TG Therapeutics Investigational Trial Site | Haifa | Israel | 91031 | |
| 124 | TG Therapeutics Investigational Trial Site | Jerusalem | Israel | 9112001 | |
| 125 | TG Therapeutics Investigational Trial Site | Nahariya | Israel | 2210001 | |
| 126 | TG Therapeutics Investigational Trial Site | Petah Tikva | Israel | 49100 | |
| 127 | TG Therapeutics Investigational Trial Site | Tel Aviv | Israel | 64239 | |
| 128 | TG Therapeutics Investigational Trial Site | Tel Aviv | Israel | 6971028 | |
| 129 | TG Therapeutics Investigational Trial Site | Bologna | Italy | 40138 | |
| 130 | TG Therapeutics Investigational Trial Site | Ferrara | Italy | 44020 | |
| 131 | TG Therapeutics Investigational Trial Site | Milan | Italy | 20132 | |
| 132 | TG Therapeutics Investigational Trial Site | Milan | Italy | 20141 | |
| 133 | TG Therapeutics Investigational Trial Site | Rome | Italy | 00161 | |
| 134 | TG Therapeutics Investigational Trial Site | Torino | Italy | 10126 | |
| 135 | TG Therapeutics Investigational Trial Site | Busan | Korea, Republic of | 47392 | |
| 136 | TG Therapeutics Investigational Trial Site | Busan | Korea, Republic of | 49241 | |
| 137 | TG Therapeutics Investigational Trial Site | Gyeonggi-do | Korea, Republic of | 13620 | |
| 138 | TG Therapeutics Investigational Trial Site | Incheon | Korea, Republic of | 21565 | |
| 139 | TG Therapeutics Investigational Trial Site | Seoul | Korea, Republic of | 03080 | |
| 140 | TG Therapeutics Investigational Trial Site | Seoul | Korea, Republic of | 06351 | |
| 141 | TG Therapeutics Investigational Trial Site | Seoul | Korea, Republic of | 06591 | |
| 142 | TG Therapeutics Investigational Trial Site | Chorzów | Poland | 41-500 | |
| 143 | TG Therapeutics Investigational Trial Site | Gdynia | Poland | 81-519 | |
| 144 | TG Therapeutics Investigational Trial Site | Kraków | Poland | 30-510 | |
| 145 | TG Therapeutics Investigational Trial Site | Lublin | Poland | 20-090 | |
| 146 | TG Therapeutics Investigational Trial Site | Słupsk | Poland | 76-200 | |
| 147 | TG Therapeutics Investigational Trial Site | Warszawa | Poland | 02-106 | |
| 148 | TG Therapeutics Investigational Trial Site | Warszawa | Poland | 02-781 | |
| 149 | TG Therapeutics Investigational Trial Site | Wrocław | Poland | 50-367 | |
| 150 | TG Therapeutics Investigational Trial Site | Łódź | Poland | 93-513 | |
| 151 | TG Therapeutics Investigational Trial Site | Bratislava | Slovakia | 81250 | |
| 152 | TG Therapeutics Investigational Trial Site | Bratislava | Slovakia | 83310 | |
| 153 | TG Therapeutics Investigational Trial Site | Košice | Slovakia | 04191 | |
| 154 | TG Therapeutics Investigational Trial Site | Poprad | Slovakia | 05801 | |
| 155 | TG Therapeutics Investigational Trial Site | Barcelona | Spain | 08035 | |
| 156 | TG Therapeutics Investigational Trial Site | Barcelona | Spain | 08041 | |
| 157 | TG Therapeutics Investigational Trial Site | Madrid | Spain | 28041 | |
| 158 | TG Therapeutics Investigational Trial Site | Madrid | Spain | 28222 | |
| 159 | TG Therapeutics Investigational Trial Site | Salisbury | Spain | 37007 | |
| 160 | TG Therapeutics Investigational Trial Site | Valencia | Spain | 46010 | |
| 161 | TG Therapeutics Investigational Trial Site | Cambridge | United Kingdom | CB2-0QQ | |
| 162 | TG Therapeutics Investigational Trial Site | Denmark Hill | United Kingdom | SE5-9RS | |
| 163 | TG Therapeutics Investigational Trial Site | Leeds | United Kingdom | LS97TF | |
| 164 | TG Therapeutics Investigational Trial Site | Liverpool | United Kingdom | L7-8XP | |
| 165 | TG Therapeutics Investigational Trial Site | London | United Kingdom | EC1A-7BE | |
| 166 | TG Therapeutics Investigational Trial Site | London | United Kingdom | SW170QT | |
| 167 | TG Therapeutics Investigational Trial Site | Oxford | United Kingdom | OX37LE | |
| 168 | TG Therapeutics Investigational Trial Site | Plymouth | United Kingdom | PL68DH |
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:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by TG Therapeutics, Inc.
Additional relevant MeSH terms: