Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
| Verified date | August 2021 |
| Source | TG Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | February 2018 |
| Est. primary completion date | February 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Refractory to or relapsed after at least 1 prior treatment regimen; - Eastern Cooperative Oncology Group (ECOG) score of 0 to 2; - At least 18 years of age. Exclusion Criteria: - Any major surgery, chemotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed = 2 weeks); - Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months; - Known hepatitis B virus, hepatitis C virus or HIV infection; - Previous therapy with GS-1101 (CAL-101), IPI-145 or any drug that specifically inhibits the PI3K or mTOR pathway; |
| Country | Name | City | State |
|---|---|---|---|
| United States | TG Therapeutics Trial Site | Cincinnati | Ohio |
| United States | TG Therapeutics Trial Site | Durham | North Carolina |
| United States | TG Therapeutics Trial Site | Hackensack | New Jersey |
| United States | TG Therapeutics Investigational Trial Site | Milwaukee | Wisconsin |
| United States | TG Therapeutics Trial Site | Nashville | Tennessee |
| United States | TG Therapeutics Trial Site | New York | New York |
| United States | TG Therapeutics Trial Site | Sarasota | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| TG Therapeutics, Inc. | SCRI Development Innovations, LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum Tolerated Dose acceptable for participants | To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities. | 28 days (1 cycle of therapy) | |
| Secondary | Overall Response Rate | To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202 | Up to 1 year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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