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The purpose of this study is to determine whether ublituximab is safe and effective in patients with relapsed or refractory B-cell lymphoma who were previously treated with rituximab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ublituximab | Experimental | Phase I: 4 cohorts with IV ublituximab starting with 450 mg followed by 600 mg, 900 mg or 1200 mg in each cohort (3 - 6 patients per cohort). Infusions will be on days 1, 8, 15 and 22 of cycle 1 followed by a planned maintenance with a single infusion monthly starting cycle 3. Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) will have infusions on Days 1, 8 and 15 of cycle 1 & 2 followed by a planned maintenance with a single infusion monthly starting cycle 3. Expansion of patient enrollment in select cohorts will apply. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ublituximab | Drug | Ublituximab is a novel monoclonal antibody targeting cluster of differentiate 20 (CD20) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Safety for all study patients will be evaluated by a Data Safety Monitoring Board to determine if feasible to continue with dose escalation | Subjects will be followed for 4 weeks |
| Maximum Tolerated Dose acceptable for participants | The Maximum Tolerated Dose will be determined by a Data Safety Monitoring Board | Subjects will be followed for 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Efficacy will include overall response rate, duration of response and progression-free survival | Participants will be evaluated approximately every 8 - 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile including Peak Plasma Concentration (Cmax)" or "Area Pharmacokinetic profile including Peak Plasma Concentration (Cmax) and Area under the plasma concentration versus time curve (AUC) | Up to 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| TG Therapeutics Clinical Trials | TG Therapeutics, Inc. | Study Director |
| 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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| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| TG Therapeutics Investigational Trial Site | Athens | Georgia | 30607 | United States |
| TG Therapeutics Investigational Trial Site | Macon | Georgia | 31201 | 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 | New York | New York | 10022 | United States |
| TG Therapeutics Investigational Trial Site | Memphis | Tennessee | 38120 | United States |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008223 | Lymphoma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| 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 |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000619007 | ublituximab |
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