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Strategic/Business Decision
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| Name | Class |
|---|---|
| James P. Wilmot Cancer Center | OTHER |
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Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ublituximab + Umbralisib + Venetoclax | Experimental | Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Venetoclax oral daily dose |
|
| Ublituximab + Umbralisib + Lenalidomide | Experimental | Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions; Umbralisib and Lenalidomide both administered days 1 - 21 of every 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | BCL-2 Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine Acceptable Adverse Events That Are Related to Treatment | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response and Complete Remission Rate | 12 months | |
| Minimum Residual Disease (MRD) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Barr, MD | Wilmot Cancer Institute - University of Rochester | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TG Therapeutics Investigational Trial Site | Chicago | Illinois | 60611 | United States | ||
| TG Therapeutics Investigational Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37871300 | Derived | Hill BT, Ma S, Zent CS, Baran AM, Wallace DS, Advani A, Winter A, Winter J, Gordan L, Karmali R, Liesveld JL, Mulford DA, Rowland C, Bui A, Sportelli P, Miskin HP, Weiss MS, Friedberg JW, Barr PM. Response-adapted, time-limited venetoclax, umbralisib, and ublituximab for relapsed/refractory chronic lymphocytic leukemia. Blood Adv. 2024 Jan 23;8(2):378-387. doi: 10.1182/bloodadvances.2023010693. |
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| Umbralisib | Drug | PI3K-Delta Inhibitor |
|
|
| Ublituximab | Biological | Glycoengineered Anti-CD20 mAb |
|
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| Lenalidomide | Drug | Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties |
|
|
| Rochester |
| New York |
| 14642 |
| United States |
| TG Therapeutics Investigational Trial Site | Cleveland | Ohio | 44195 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2023 | Jun 21, 2023 | 46 |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| 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 |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| C000626319 | umbralisib |
| C000619007 | ublituximab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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