Evaluate the Efficacy and Safety of TGR-1202 in Patients With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy
Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02742090
Collaborator
(none)
51
15
1
61.6
3.4
0.1
Study Details
Study Description
Brief Summary
This is a Phase 2, open-label, study of TGR-1202, a PI3K delta inhibitor, administered as a single agent in Chronic Lymphocytic Leukemia (CLL) patients who are intolerant to prior BTK inhibitors (ibrutinib, other) or prior PI3K delta inhibitors (idelalisib, other)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
51 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK (Bruton Tyrosine Kinase) or PI3K-Delta (Phosphoinositide-3-kinase) Inhibitor Therapy
Actual Study Start Date
:
Apr 21, 2016
Actual Primary Completion Date
:
Jun 10, 2021
Actual Study Completion Date
:
Jun 10, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TGR-1202 Oral daily dose of TGR-1202 |
Drug: TGR-1202
|
Outcome Measures
Primary Outcome Measures
- Progression-free Survival [From date of enrollment until the date of first documented progression, assessed up through 2 years]
Secondary Outcome Measures
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [12 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
-
Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months
-
Presence of measurable disease
Exclusion Criteria:
-
Progression on prior BTK or PI3K delta inhibitor
-
Prior treatment with TGR-1202
-
Richter's transformation or CLL transformation to aggressive lymphoma
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 | Washington | District of Columbia | United States | 20007 |
| 3 | TG Therapeutics Investigational Trial Site | Fort Myers | Florida | United States | 33916 |
| 4 | TG Therapeutics Investigational Trial Site | Saint Petersburg | Florida | United States | 33705 |
| 5 | TG Therapeutics Investigational Trial Site | Kansas City | Missouri | United States | 64132 |
| 6 | TG Therapeutics Investigational Trial Site | Lebanon | New Hampshire | United States | 03756 |
| 7 | TG Therapeutics Investigational Trial Site | Hackensack | New Jersey | United States | 07601 |
| 8 | TG Therapeutics Investigational Trial Site | New Hyde Park | New York | United States | 11042 |
| 9 | TG Therapeutics Investigational Trial Site | New York | New York | United States | 10032 |
| 10 | TG Therapeutics Investigational Trial Site | Rochester | New York | United States | 14642 |
| 11 | TG Therapeutics Investigational Trial Site | Durham | North Carolina | United States | 27710 |
| 12 | TG Therapeutics Investigational Trial Site | Hershey | Pennsylvania | United States | 17033 |
| 13 | TG Therapeutics Investigational Trial Site | Philadelphia | Pennsylvania | United States | 19146 |
| 14 | TG Therapeutics Investigational Trial Site | Nashville | Tennessee | United States | 37203 |
| 15 | TG Therapeutics Investigational Trial Site | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- TG Therapeutics, Inc.
Investigators
- Study Chair: Anthony Mato, MD, University of Pennsylvania Center for CLL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
TG Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02742090
Other Study ID Numbers:
- TGR-1202-201-CLL
First Posted:
Apr 18, 2016
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by TG Therapeutics, Inc.
Additional relevant MeSH terms: