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
Terminated
CT.gov ID
NCT02656303
Collaborator
(none)
116
87
1
78.1
1.3
0
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
116 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
Actual Primary Completion Date
:
May 26, 2022
Actual Study Completion Date
:
Jul 11, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ublituximab + TGR-1202 Ublituximab IV treatment + TGR-1202 oral daily dose |
Biological: ublituximab
ublituximab IV infusion
Other Names:
Drug: TGR-1202
TGR-1202 oral daily dose
|
Outcome Measures
Primary Outcome Measures
- 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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | TG Therapeutics Investigational Trial Site | Huntsville | Alabama | United States | 35805 |
| 2 | TG Therapeutics Investigational Trial Site | Chandler | Arizona | United States | 85224 |
| 3 | TG Therapeutics Investigational Trial Site | Fayetteville | Arkansas | United States | 72703 |
| 4 | TG Therapeutics Investigational Trial Site | Duarte | California | United States | 91010 |
| 5 | TG Therapeutics Investigational Trial Site | Pleasanton | California | United States | 94588 |
| 6 | TG Therapeutics Investigational Trial Site | San Diego | California | United States | 92108 |
| 7 | TG Therapeutics Investigational Trial Site | Whittier | California | United States | 90603 |
| 8 | TG Therapeutics Investigational Trial Site | Aurora | Colorado | United States | 80012 |
| 9 | TG Therapeutics Investigational Trial Site | Denver | Colorado | United States | 80218 |
| 10 | TG Therapeutics Investigational Trial Site | Bridgeport | Connecticut | United States | 06606 |
| 11 | TG Therapeutics Investigational Trial Site | New Haven | Connecticut | United States | 06519 |
| 12 | TG Therapeutics Investigational Trial Site | Stamford | Connecticut | United States | 06904 |
| 13 | TG Therapeutics Investigational Trial Site | Newark | Delaware | United States | 19713 |
| 14 | TG Therapeutics Investigational Trial Site | Boca Raton | Florida | United States | 33486 |
| 15 | TG Therapeutics Investigational Trial Site | Fort Myers | Florida | United States | 33916 |
| 16 | TG Therapeutics Investigational Trial Site | Jacksonville | Florida | United States | 32204 |
| 17 | TG Therapeutics Investigational Trial Site | Jacksonville | Florida | United States | 32256 |
| 18 | TG Therapeutics Investigational Trial Site | Saint Petersburg | Florida | United States | 33705 |
| 19 | TG Therapeutics Investigational Trial Site | Tallahassee | Florida | United States | 32308 |
| 20 | TG Therapeutics Investigational Trial Site | West Palm Beach | Florida | United States | 33401 |
| 21 | TG Therapeutics Investigational Trial Site | Albany | Georgia | United States | 31701 |
| 22 | TG Therapeutics Investigational Trial Site | Chicago | Illinois | United States | 60612 |
| 23 | TG Therapeutics Investigational Trial Site | Peoria | Illinois | United States | 61615 |
| 24 | TG Therapeutics Investigational Trial Site | Swansea | Illinois | United States | 62526 |
| 25 | TG Therapeutics Investigational Trial Site | Urbana | Illinois | United States | 61801 |
| 26 | TG Therapeutics Investigational Trial Site | Fort Wayne | Indiana | United States | 46804 |
| 27 | TG Therapeutics Investigational Trial Site | Indianapolis | Indiana | United States | 46237 |
| 28 | TG Therapeutics Investigational Trial Site | Westwood | Kansas | United States | 66210 |
| 29 | TG Therapeutics Investigational Trial Site | Louisville | Kentucky | United States | 40207 |
| 30 | TG Therapeutics Investigational Trial Site | Worcester | Massachusetts | United States | 01608 |
| 31 | TG Therapeutics Investigational Trial Site | Ann Arbor | Michigan | United States | 48197 |
| 32 | TG Therapeutics Investigational Trial Site | Detroit | Michigan | United States | 48202 |
| 33 | TG Therapeutics Investigational Trial Site | Jackson | Michigan | United States | 49201 |
| 34 | TG Therapeutics Investigational Trial Site | Saint Louis Park | Minnesota | United States | 55416 |
| 35 | TG Therapeutics Investigational Trial Site | Kansas City | Missouri | United States | 64132 |
| 36 | TG Therapeutics Investigational Trial Site | Lincoln | Nebraska | United States | 68510 |
| 37 | TG Therapeutics Investigational Trial Site | Lebanon | New Hampshire | United States | 03756 |
| 38 | TG Therapeutics Investigational Trial Site | Morristown | New Jersey | United States | 07932 |
| 39 | TG Therapeutics Investigational Trial Site | Glens Falls | New York | United States | 12801 |
| 40 | TG Therapeutics Investigational Trial Site | Syracuse | New York | United States | 13210 |
| 41 | TG Therapeutics Investigational Trial Site | Charlotte | North Carolina | United States | 28204 |
| 42 | TG Therapeutics Investigational Trial Site | Durham | North Carolina | United States | 27705 |
| 43 | TG Therapeutics Investigational Trial Site | Durham | North Carolina | United States | 27710 |
| 44 | TG Therapeutics Investigational Trial Site | Hickory | North Carolina | United States | 28602 |
| 45 | TG Therapeutics Investigational Trial Site | Kinston | North Carolina | United States | 28501 |
| 46 | TG Therapeutics Investigational Trial Site | Washington | North Carolina | United States | 27889 |
| 47 | TG Therapeutics Investigational Trial Site | Canton | Ohio | United States | 44718 |
| 48 | TG Therapeutics Investigational Trial Site | Toledo | Ohio | United States | 43623 |
| 49 | TG Therapeutics Investigational Trial Site | Portland | Oregon | United States | 97227 |
| 50 | TG Therapeutics Investigational Trial Site | Portland | Oregon | United States | 98684 |
| 51 | TG Therapeutics Investigational Trial Site | Springfield | Oregon | United States | 97477 |
| 52 | TG Therapeutics Investigational Trial Site | Camp Hill | Pennsylvania | United States | 17011 |
| 53 | TG Therapeutics Investigational Trial Site | Hershey | Pennsylvania | United States | 17033 |
| 54 | TG Therapeutics Investigational Trial Site | Philadelphia | Pennsylvania | United States | 19106 |
| 55 | TG Therapeutics Investigational Trial Site | Pittsburgh | Pennsylvania | United States | 15224 |
| 56 | TG Therapeutics Investigational Trial Site | Pawtucket | Rhode Island | United States | 02860 |
| 57 | TG Therapeutics Investigational Trial Site | Greenville | South Carolina | United States | 29605 |
| 58 | TG Therapeutics Investigational Trial Site | Sioux Falls | South Dakota | United States | 57105 |
| 59 | TG Therapeutics Investigational Trial Site | Chattanooga | Tennessee | United States | 37404 |
| 60 | TG Therapeutics Investigational Trial Site | Nashville | Tennessee | United States | 37203 |
| 61 | TG Therapeutics Investigational Trial Site | Fort Worth | Texas | United States | 76104 |
| 62 | TG Therapeutics Investigational Trial Site | San Antonio | Texas | United States | 78240 |
| 63 | TG Therapeutics Investigational Trial Site | Ogden | Utah | United States | 84405 |
| 64 | TG Therapeutics Investigational Trial Site | Blacksburg | Virginia | United States | 24060 |
| 65 | TG Therapeutics Investigational Trial Site | Charlottesville | Virginia | United States | 22908 |
| 66 | TG Therapeutics Investigational Trial Site | Fort Belvoir | Virginia | United States | 22060 |
| 67 | TG Therapeutics Investigational Trial Site | Seattle | Washington | United States | 98109 |
| 68 | TG Therapeutics Investigational Trial Site | Spokane | Washington | United States | 99216 |
| 69 | TG Therapeutics Investigational Trial Site | Wauwatosa | Wisconsin | United States | 53226 |
| 70 | TG Therapeutics Investigational Trial Site | Ferrara | Italy | 44020 | |
| 71 | TG Therapeutics Investigational Trial Site | Milan | Italy | 20132 | |
| 72 | TG Therapeutics Investigational Trial Site | Milan | Italy | 20141 | |
| 73 | TG Therapeutics Investigational Trial Site | Torino | Italy | 10126 | |
| 74 | TG Therapeutics Investigational Trial Site | Chorzów | Poland | 41-500 | |
| 75 | TG Therapeutics Investigational Trial Site | Gdynia | Poland | 81-519 | |
| 76 | TG Therapeutics Investigational Trial Site | Kraków | Poland | 30-510 | |
| 77 | TG Therapeutics Investigational Trial Site | Lublin | Poland | 20-090 | |
| 78 | TG Therapeutics Investigational Trial Site | Słupsk | Poland | 76-200 | |
| 79 | TG Therapeutics Investigational Trial Site | Warszawa | Poland | 02-106 | |
| 80 | TG Therapeutics Investigational Trial Site | Warszawa | Poland | 02-776 | |
| 81 | TG Therapeutics Investigational Trial Site | Warszawa | Poland | 02-781 | |
| 82 | TG Therapeutics Investigational Trial Site | Warszawa | Poland | 50-367 | |
| 83 | TG Therapeutics Investigational Trial Site | Łódź | Poland | 93-513 | |
| 84 | TG Therapeutics Investigational Trial Site | London | United Kingdom | SW170QT | |
| 85 | TG Therapeutics Investigational Trial Site | Norwich | United Kingdom | NR47UY | |
| 86 | TG Therapeutics Investigational Trial Site | Sunderland | United Kingdom | SR47TP | |
| 87 | TG Therapeutics Investigational Trial Site | Wolverhampton | United Kingdom | WV100QP |
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:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Additional relevant MeSH terms: