Chronic Lymphocytic Leukemia Clinical Trial
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
| Verified date | June 2022 |
| Source | TG Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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)
| Status | Completed |
| Enrollment | 51 |
| Est. completion date | June 10, 2021 |
| Est. primary completion date | June 10, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | TG Therapeutics Investigational Trial Site | Durham | North Carolina |
| United States | TG Therapeutics Investigational Trial Site | Fort Myers | Florida |
| United States | TG Therapeutics Investigational Trial Site | Hackensack | New Jersey |
| United States | TG Therapeutics Investigational Trial Site | Hershey | Pennsylvania |
| United States | TG Therapeutics Investigational Trial Site | Huntsville | Alabama |
| United States | TG Therapeutics Investigational Trial Site | Kansas City | Missouri |
| United States | TG Therapeutics Investigational Trial Site | Lebanon | New Hampshire |
| United States | TG Therapeutics Investigational Trial Site | Nashville | Tennessee |
| United States | TG Therapeutics Investigational Trial Site | New Hyde Park | New York |
| United States | TG Therapeutics Investigational Trial Site | New York | New York |
| United States | TG Therapeutics Investigational Trial Site | Philadelphia | Pennsylvania |
| United States | TG Therapeutics Investigational Trial Site | Rochester | New York |
| United States | TG Therapeutics Investigational Trial Site | Saint Petersburg | Florida |
| United States | TG Therapeutics Investigational Trial Site | Seattle | Washington |
| United States | TG Therapeutics Investigational Trial Site | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| TG Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free Survival | From date of enrollment until the date of first documented progression, assessed up through 2 years | ||
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 12 months |
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