UNITY-CLL: Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Patients With Untreated and Previously Treated Chronic Lymphocytic Leukemia
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
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:
Drug: Chlorambucil
Chlorambucil: Oral dose
Other Names:
|
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
- 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
- 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
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 | |
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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.- UTX-TGR-304