Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TGR-1202 + brentuximab vedotin | Experimental | TGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TGR-1202 + brentuximab vedotin | Drug | TGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | To evaluate the duration of response of TGR-1202 in combination with brentuximab vedotin | Up to 1 year |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TG Therapeutics Investigational Trial Site | Duarte | California | 91010 | United States | ||
| TG Therapeutics Investigational Trial Site |
Not provided
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000626319 | umbralisib |
| D000079963 | Brentuximab Vedotin |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| San Diego |
| California |
| 92093 |
| United States |
| TG Therapeutics Investigational Trial Site | Sarasota | Florida | 34232 | United States |
| TG Therapeutics Investigational Trial Site | Detroit | Michigan | 48201 | United States |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |