Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase I/Ib Study Evaluating the Efficacy and Safety of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Combination With TGR-1202, a Novel PI3k Delta Inhibitor; and Ibrutinib or Bendamustine, in Patients With B-cell Malignancies.
| Verified date | November 2019 |
| 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 Ublituximab in combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with advanced hematologic malignancies
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | October 2019 |
| Est. primary completion date | October 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Confirmed B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and other B-cell lymphoproliferative disorders as approved by the Medical Monitor or Study Chair - Refractory to or relapsed after at least 1 prior treatment regimen - Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: - Any major surgery, chemotherapy or immunotherapy within the last 21 days - Known hepatitis B virus, hepatitis C virus or HIV infection - Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months - Primary central nervous system lymphoma or known intracranial involvement |
| Country | Name | City | State |
|---|---|---|---|
| United States | TG Therapeutics Investigational Trial Site | Atlanta | Georgia |
| United States | TG Therapeutics Investigational Trial Site | Duarte | California |
| United States | MD Anderson Cancer Center | Houston | Texas |
| United States | TG Therapeutics Investigational Trial Site | Huntsville | Alabama |
| United States | TG Therapeutics Investigational Trial Site | Jonesboro | Arkansas |
| United States | TG Therapeutics Investigational Trial Site | Omaha | Nebraska |
| Lead Sponsor | Collaborator |
|---|---|
| TG Therapeutics, Inc. |
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 Ublituximab in combination with TGR-1202 | Up to 1 year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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