Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials
Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03207256
Collaborator
(none)
51
17
2
58.5
3
0.1
Study Details
Study Description
Brief Summary
This is an open label compassionate use trial of Ublituximab and TGR-1202 in combination or as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202 trials with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
51 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Extension Trial of Ublituximab and/or Umbralisib (TGR-1202) in Combination With Other Novel Agents or as Single Agents in Subjects Currently Receiving Treatment on a TG Therapeutics Study.
Actual Study Start Date
:
Aug 9, 2017
Actual Primary Completion Date
:
May 25, 2022
Actual Study Completion Date
:
Jun 24, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TGR-1202 Oral TGR-1202 Daily |
Drug: TGR-1202
Oral Daily TGR-1202
|
| Experimental: TGR-1202 + Ublituximab Oral TGR-1202 in combination with Ublituximab intravenous administration |
Drug: TGR-1202 + Ublituximab
Oral Daily TGR-1202 + Ublituximab IV Administration
|
Outcome Measures
Primary Outcome Measures
- Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities [Evaluated at each planned visit through study completion, an average of 2 years]
Toxicity according to the investigator (Adverse events with NCI-CTC 4.0)
Secondary Outcome Measures
- Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment [Evaluated at each planned visit through study completion, an average of 2 years]
Date of progression reported for each patient
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects must be currently receiving treatment with ublituximab and/or TGR-1202 on a previously approved protocol.
-
Subjects must have completed at least 6 cycles of therapy on their current protocol.
Exclusion Criteria:
- Subject progressed while receiving therapy with ublituximab and/or TGR-1202 while participating in their immediate previous trial.
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 | Tucson | Arizona | United States | 85711 |
| 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 | Fort Myers | Florida | United States | 33901 |
| 6 | TG Therapeutics Investigational Trial Site | Atlanta | Georgia | United States | 30322 |
| 7 | TG Therapeutics Investigational Trial Site | Fort Wayne | Indiana | United States | 46804 |
| 8 | TG Therapeutics Investigational Trial Site | Coon Rapids | Minnesota | United States | 55433 |
| 9 | TG Therapeutics Investigational Trial Site | Omaha | Nebraska | United States | 68198 |
| 10 | TG Therapeutics Investigational Trial Site | Durham | North Carolina | United States | 27710 |
| 11 | TG Therapeutics Investigational Site | Canton | Ohio | United States | 44718 |
| 12 | TG Therapeutics Investigational Trial Site | Cincinnati | Ohio | United States | 45242 |
| 13 | TG Therapeutics Investigational Trial Site | Nashville | Tennessee | United States | 37203 |
| 14 | TG Therapeutics Investigational Trial Site | Denton | Texas | United States | 76210 |
| 15 | TG Therapeutics Investigational Trial Site | San Antonio | Texas | United States | 78229 |
| 16 | TG Therapeutics Investigational Trial Site | Seattle | Washington | United States | 98104 |
| 17 | TG Therapeutics Investigational Trial Site | Milwaukee | Wisconsin | United States | 53226 |
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:
NCT03207256
Other Study ID Numbers:
- UTX-TGR-501
First Posted:
Jul 2, 2017
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: