Hodgkin's Lymphoma Clinical Trial
Official title:
A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of Brentuximab Vedotin in Combination With TGR-1202, a Novel PI3K Delta Inhibitor, in Patients With Hodgkins Lymphoma
| NCT number | NCT02164006 |
| Other study ID # | TGR-BV-107 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | June 11, 2014 |
| Est. completion date | May 2016 |
| Verified date | October 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 TGR-1202 in combination with brentuximab vedotin in patients with hodgkin's lymphoma.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | May 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Confirmed diagnosis of Hodgkin's Lymphoma - Relapsed or refractory after an autologous stem cell transplant (ASCT) or at least two prior multi-agent chemotherapy regimens in patients not candidates for ASCT - 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. Patients who had prior Allogeneic hematologic stem cell transplant are excluded |
| Country | Name | City | State |
|---|---|---|---|
| United States | TG Therapeutics Investigational Trial Site | Detroit | Michigan |
| United States | TG Therapeutics Investigational Trial Site | Duarte | California |
| United States | TG Therapeutics Investigational Trial Site | San Diego | California |
| United States | TG Therapeutics Investigational Trial Site | Sarasota | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| TG Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Duration of Response | To evaluate the duration of response of TGR-1202 in combination with brentuximab vedotin | Up to 1 year | |
| Primary | Maximum Tolerated Dose acceptable for participants | To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities | 21 days (1 cycle of therapy) | |
| Secondary | Overall Response Rate | To assess the overall response rate (ORR) of TGR-1202 in combination with brentuximab vedotin in patients with Hodgkin's lymphoma | Up to 1 year |
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