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| Name | Class |
|---|---|
| SCRI Development Innovations, LLC | OTHER |
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The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TGR-1202 | Experimental | TGR-1202 Daily Oral Dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TGR-1202 | Drug | TGR-1202 Daily Oral Dose |
|
| 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. | 28 days (1 cycle of therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | To assess the overall response rate (ORR) in patients with hematologic malignancies treated with TGR-1202 | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard Burris, MD, FACP | SCRI Development Innovations, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TG Therapeutics Trial Site | Sarasota | Florida | 34232 | United States | ||
| TG Therapeutics Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29475723 | Derived | Burris HA 3rd, Flinn IW, Patel MR, Fenske TS, Deng C, Brander DM, Gutierrez M, Essell JH, Kuhn JG, Miskin HP, Sportelli P, Weiss MS, Vakkalanka S, Savona MR, O'Connor OA. Umbralisib, a novel PI3Kdelta and casein kinase-1epsilon inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study. Lancet Oncol. 2018 Apr;19(4):486-496. doi: 10.1016/S1470-2045(18)30082-2. Epub 2018 Feb 20. |
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| Hackensack |
| New Jersey |
| 07601 |
| United States |
| TG Therapeutics Trial Site | New York | New York | 10019 | United States |
| TG Therapeutics Trial Site | Durham | North Carolina | 27710 | United States |
| TG Therapeutics Trial Site | Cincinnati | Ohio | 45242 | United States |
| TG Therapeutics Trial Site | Nashville | Tennessee | 37203 | United States |
| TG Therapeutics Investigational Trial Site | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016399 | Lymphoma, T-Cell |
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| ID | Term |
|---|---|
| C000626319 | umbralisib |
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