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| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
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The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG-1501 + Ublituximab + Umbralisib | Experimental | Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbralisib | Drug | A once daily oral agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine Acceptable Adverse Events That Are Related to Treatment | To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities | 6 months of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | The overall response rate (ORR) in patients with CLL and Richter's Transformation treated with Ublituximab in combination with Umbralisib and Targeted Immunotherapy | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony R. Mato, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TG Therapeutics Investigational Trial Site | New York | New York | 10065 | United States | ||
| TG Therapeutics Investigational Trial Site |
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| ublituximab | Biological | IV anti-CD20 monoclonal antibody |
|
|
| TG-1501 | Biological | IV immunotherapy for cancer |
|
| Durham |
| North Carolina |
| 27710 |
| United States |
| TG Therapeutics Investigational Trial Site | Philadelphia | Pennsylvania | 19104 | United States |
| TG Therapeutics Investigational Trial Site | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000626319 | umbralisib |
| C000619007 | ublituximab |
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