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The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ublituximab + ibrutinib | Experimental | Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ublituximab | Drug | Ublituximab (IV infusion) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies | 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 Ublituximab in combination with Ibrutinib | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Sharman, MD | Willamette Valley Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TG Therapeutics Investigational Trial Site | Huntsville | Alabama | 35805 | United States | ||
| TG Therapeutics Investigational Trial Site |
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| Ibrutinib |
| Drug |
Ibrutinib oral daily dose |
|
|
| Tucson |
| Arizona |
| 85710 |
| United States |
| TG Therapeutics Investigational Trial Site | Santa Barbara | California | 93105 | United States |
| TG Therapeutics Investigational Trial Site | Boulder | Colorado | 80303 | United States |
| TG Therapeutics Investigational Trial Site | Niles | Illinois | 60714 | United States |
| TG Therapeutics Investigational Trial Site | Urbana | Illinois | 61801 | United States |
| TG Therapeutics Investigational Trial Site | Bethesda | Maryland | 20817 | United States |
| TG Therapeutics Investigational Trial Site | Morristown | New Jersey | 07962 | United States |
| TG Therapeutics Investigational Trial Site | Portland | Oregon | 97213 | United States |
| TG Therapeutics Investigational Trial Site | Springfield | Oregon | 97477 | United States |
| TG Therapeutics Investigational Trial Site | Greenville | South Carolina | 29615 | United States |
| TG Therapeutics Investigational Trial Site | Memphis | Tennessee | 38120 | United States |
| TG Therapeutics Investigational Trial Site | Austin | Texas | 78705 | United States |
| TG Therapeutics Investigational Trial Site | Dallas | Texas | 75230 | United States |
| TG Therapeutics Investigational Trial Site | Tyler | Texas | 75702 | United States |
| TG Therapeutics Investigational Trial Site | Blacksburg | Virginia | 24060 | United States |
| TG Therapeutics Investigational Trial Site | Fairfax | Virginia | 22031 | United States |
| TG Therapeutics Investigational Trial Site | Vancouver | Washington | 98684 | United States |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D020522 | Lymphoma, Mantle-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 |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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| ID | Term |
|---|---|
| C000619007 | ublituximab |
| C551803 | ibrutinib |
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