Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)
Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03801525
Collaborator
(none)
700
50
7
71.5
14
0.2
Study Details
Study Description
Brief Summary
ULTRA-V: Study to Assess the Efficacy and Safety of Ublituximab in Combination with Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with Chronic Lymphocytic Leukemia (CLL)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
Detailed Description
This is an open-label, multicenter, Phase 2/3 study to evaluate the efficacy and safety of the combination of ublituximab + umbralisib + venetoclax (U2-V) compared to the combination of ublituximab + umbralisib (U2) in patients with either treatment naïve or previously treated CLL/ small lymphocytic lymphoma (SLL)
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
700 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2/3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects With Chronic Lymphocytic Leukemia (CLL)
Actual Study Start Date
:
May 16, 2019
Anticipated Primary Completion Date
:
Jan 1, 2025
Anticipated Study Completion Date
:
May 1, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Phase 2: Previously Treated CLL (BTK-Not Refractory)
|
Drug: Ublituximab
recombinant chimeric anti-CD20 (cluster of differentiation 20) monoclonal antibody
administered as an intravenous (IV) infusion
Other Names:
Drug: Umbralisib
inhibitor of phosphoinositide 3-kinase (PI3K) delta and casein kinase 1 epsilon (CK1e)
Tablet form
Other Names:
Drug: Venetoclax
B-cell lymphoma 2 (BCL-2) inhibitor
Tablet form, to be taken orally
Other Names:
|
| Experimental: Phase 2: Previously Treated CLL (BTK-Refractory)
|
Drug: Ublituximab
recombinant chimeric anti-CD20 (cluster of differentiation 20) monoclonal antibody
administered as an intravenous (IV) infusion
Other Names:
Drug: Umbralisib
inhibitor of phosphoinositide 3-kinase (PI3K) delta and casein kinase 1 epsilon (CK1e)
Tablet form
Other Names:
Drug: Venetoclax
B-cell lymphoma 2 (BCL-2) inhibitor
Tablet form, to be taken orally
Other Names:
|
| Experimental: Phase 2: Treatment Naïve CLL
|
Drug: Ublituximab
recombinant chimeric anti-CD20 (cluster of differentiation 20) monoclonal antibody
administered as an intravenous (IV) infusion
Other Names:
Drug: Umbralisib
inhibitor of phosphoinositide 3-kinase (PI3K) delta and casein kinase 1 epsilon (CK1e)
Tablet form
Other Names:
Drug: Venetoclax
B-cell lymphoma 2 (BCL-2) inhibitor
Tablet form, to be taken orally
Other Names:
|
| Experimental: Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
|
Drug: Ublituximab
recombinant chimeric anti-CD20 (cluster of differentiation 20) monoclonal antibody
administered as an intravenous (IV) infusion
Other Names:
Drug: Umbralisib
inhibitor of phosphoinositide 3-kinase (PI3K) delta and casein kinase 1 epsilon (CK1e)
Tablet form
Other Names:
Drug: Venetoclax
B-cell lymphoma 2 (BCL-2) inhibitor
Tablet form, to be taken orally
Other Names:
|
| Experimental: Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib (U2)
|
Drug: Ublituximab
recombinant chimeric anti-CD20 (cluster of differentiation 20) monoclonal antibody
administered as an intravenous (IV) infusion
Other Names:
Drug: Umbralisib
inhibitor of phosphoinositide 3-kinase (PI3K) delta and casein kinase 1 epsilon (CK1e)
Tablet form
Other Names:
|
| Experimental: Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
|
Drug: Ublituximab
recombinant chimeric anti-CD20 (cluster of differentiation 20) monoclonal antibody
administered as an intravenous (IV) infusion
Other Names:
Drug: Umbralisib
inhibitor of phosphoinositide 3-kinase (PI3K) delta and casein kinase 1 epsilon (CK1e)
Tablet form
Other Names:
Drug: Venetoclax
B-cell lymphoma 2 (BCL-2) inhibitor
Tablet form, to be taken orally
Other Names:
|
| Experimental: Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib (U2)
|
Drug: Ublituximab
recombinant chimeric anti-CD20 (cluster of differentiation 20) monoclonal antibody
administered as an intravenous (IV) infusion
Other Names:
Drug: Umbralisib
inhibitor of phosphoinositide 3-kinase (PI3K) delta and casein kinase 1 epsilon (CK1e)
Tablet form
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Phase 2: Complete Response (CR) Rate [Up to 12 months]
- Phase 2: Overall Response Rate [Up to 12 months]
- Phase 3: Progression-Free Survival [60 months]
Progression-Free Survival in subjects treated with U2-V compared with U2
Secondary Outcome Measures
- Adverse Events That Are Related to Treatment [6 months of therapy]
Number of Participants With Treatment-Related Adverse Event and any potential abnormal laboratory results
- Phase 3: Overall Response Rate [Up to 12 months]
Objective response in subjects treated with ublituximab + umbralisib + venetoclax
- Rate of Undetectable Minimal Residual Disease (MRD) [60 months]
- Phase 2: Time to Response (TTR) [Up to 12 months]
- Phase 2: Duration of Response (DOR) [60 months]
- Phase 3: Complete Response (CR) Rate [Up to 12 months]
- Phase 3: Overall Survival (OS) [72 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that warrants treatment
-
Adequate organ system function as specified in the protocol
-
Ability to follow protocol procedures.
Exclusion Criteria:
-
Subjects receiving cancer therapy or any investigational drug within 21 days of Cycle 1, Day 1
-
Prior exposure to any PI3K inhibitor or venetoclax
-
Autologous hematologic stem cell transplant within 6 months of study entry. Prior allogeneic hematologic stem cell transplant is excluded
-
Active Hepatitis B or Hepatitis C.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | TG Therapeutics Investigational Trial Site | Birmingham | Alabama | United States | 35294 |
| 2 | TG Therapeutics Investigational Trial Site | Huntsville | Alabama | United States | 35805 |
| 3 | TG Therapeutics Investigational Trial Site | Tucson | Arizona | United States | 85711 |
| 4 | TG Therapeutics Investigational Trial Site | Duarte | California | United States | 91010 |
| 5 | TG Therapeutics Investigational Trial Site | La Jolla | California | United States | 92093 |
| 6 | TG Therapeutics Investigational Trial Site | Aurora | Colorado | United States | 80012 |
| 7 | TG Therapeutics Investigational Trial Site | Stamford | Connecticut | United States | 06904 |
| 8 | TG Therapeutics Investigational Trial Site | Boca Raton | Florida | United States | 33486 |
| 9 | TG Therapeutics Investigational Trial Site | Fort Myers | Florida | United States | 33901 |
| 10 | TG Therapeutics Investigational Trial Site | Jacksonville | Florida | United States | 32224 |
| 11 | TG Therapeutics Investigational Trial Site | Saint Petersburg | Florida | United States | 33705 |
| 12 | TG Therapeutics Investigational Trial Site | Tampa | Florida | United States | 33612 |
| 13 | TG Therapeutics Investigational Trial Site | Atlanta | Georgia | United States | 30322 |
| 14 | TG Therapeutics Investigational Trial Site | Decatur | Illinois | United States | 62526 |
| 15 | TG Therapeutics Investigational Trial Site | Niles | Illinois | United States | 60714 |
| 16 | TG Therapeutics Investigational Site | Peoria | Illinois | United States | 61615 |
| 17 | TG Therapeutics Investigational Trial Site | Fort Wayne | Indiana | United States | 46804 |
| 18 | TG Therapeutics Investigational Trial Site | Indianapolis | Indiana | United States | 46237 |
| 19 | TG Therapeutics Investigational Trial Site | Des Moines | Iowa | United States | 50309 |
| 20 | TG Therapeutics Investigational Trial Site | Westwood | Kansas | United States | 66210 |
| 21 | TG Therapeutics Investigational Site | Louisville | Kentucky | United States | 40207 |
| 22 | TG Therapeutics Investigational Trial Site | Bethesda | Maryland | United States | 37210 |
| 23 | TG Therapeutics Investigational Trial Site | Columbia | Maryland | United States | 21044 |
| 24 | TG Therapeutics Investigational Trial Site | Ann Arbor | Michigan | United States | 48197 |
| 25 | TG Therapeutics Investigational Trial Site | Detroit | Michigan | United States | 48201 |
| 26 | TG Therapeutics Investigational Trial Site | Detroit | Michigan | United States | 48202 |
| 27 | TG Therapeutics Investigational Trial Site | Rochester | Minnesota | United States | 55905 |
| 28 | TG Therapeutics Investigational Trial Site | Omaha | Nebraska | United States | 68198 |
| 29 | TG Therapeutics Investigational Trial Site | Lebanon | New Hampshire | United States | 03756 |
| 30 | TG Therapeutics Investigational Trial Site | Hackensack | New Jersey | United States | 07601 |
| 31 | TG Therapeutics Investigational Trial Site | Morristown | New Jersey | United States | 07960 |
| 32 | TG Therapeutics Investigational Trial Site | New York | New York | United States | 10065 |
| 33 | TG Therapeutics Investigational Trial Site | Charlotte | North Carolina | United States | 28204 |
| 34 | TG Therapeutics Investigational Trial Site | Columbus | Ohio | United States | 43210 |
| 35 | TG Therapeutics Investigational Trial Site | Eugene | Oregon | United States | 97401 |
| 36 | TG Therapeutics Investigational Trial Site | Philadelphia | Pennsylvania | United States | 19106 |
| 37 | TG Therapeutics Investigational Trial Site | Charleston | South Carolina | United States | 29414 |
| 38 | TG Therapeutics Investigational Trial Site | Greenville | South Carolina | United States | 29616 |
| 39 | TG Therapeutics Investigational Trial Site | Chattanooga | Tennessee | United States | 37404 |
| 40 | TG Therapeutics Investigational Trial Site | Knoxville | Tennessee | United States | 37916 |
| 41 | TG Therapeutics Investigational Trial Site | Nashville | Tennessee | United States | 37203 |
| 42 | TG Therapeutics Investigational Trial Site | Austin | Texas | United States | 78705 |
| 43 | TG Therapeutics Investigational Trial Site | San Antonio | Texas | United States | 78229 |
| 44 | TG Therapeutics Investigational Trial Site | Tyler | Texas | United States | 75702 |
| 45 | TG Therapeutics Investigational Trial Site | Ogden | Utah | United States | 84405 |
| 46 | TG Therapeutics Investigational Trial Site | Salt Lake City | Utah | United States | 84106 |
| 47 | TG Therapeutics Investigational Trial Site | Blacksburg | Virginia | United States | 24060 |
| 48 | TG Therapeutics Investigational Trial Site | Gainesville | Virginia | United States | 20155 |
| 49 | TG Therapeutics Investigational Trial Site | Seattle | Washington | United States | 98104 |
| 50 | TG Therapeutics Investigational Trial Site | Seattle | Washington | United States | 98108 |
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:
NCT03801525
Other Study ID Numbers:
- U2-VEN-207
First Posted:
Jan 11, 2019
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by TG Therapeutics, Inc.
Additional relevant MeSH terms: