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Strategic/Business Decision
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This is a phase 2, open label study to assess umbralisib in combination with ublituximab in participants with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).
The study will assess the safety and efficacy of umbralisib in combination with ublituximab in participants with treatment naïve FL and SLL. Ublituximab will be administered through Cycle 12, while umbralisib will be administered through Cycle 24. After this time, participants will be followed for progression free survival (PFS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ublituximab + Umbralisib | Experimental | Participants were administered ublituximab, 900 milligrams (mg), intravenous (IV) infusion through Cycles 1-6, Cycles 9 and 12. Participants also received umbralisib, 800 mg, oral tablet, daily through Cycles 1-24. 1 Cycle = 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ublituximab | Drug | - anti-CD 20 monoclonal antibody administered via IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR was defined as sum of participants with partial responses (PR) and complete responses (CR). CR was defined as complete disappearance of all evidence of disease and disease-related symptoms. PR was defined as regression of measurable disease and no new sites of disease. Regression= ≥ 50% decrease in sum of the products of diameters (SPD) of index lesions, with no unequivocal increase in size of other lymph nodes, liver, or spleen. | Up to 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was defined as the interval from Cycle 1/Day 1 to the earlier of the first documentation of definitive disease progression or death from any cause. Appearance of any new lesion more than 1.5 cm in any axis, even if other lesions were decreasing in size was considered relapsed or progressive disease. At least a 50% increase from nadir in one of the following: SPD of index lesions, greatest transverse diameter (GTD) of any individual previously involved node, or GTD of any previously involved node provided that the GTD of that node was ≥ 1.5 cm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TG Therapeutics Investigational Trial Site | Fort Myers | Florida | 33901 | United States | ||
| TG Therapeutics Investigational Trial Site |
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A total of 34 participants were enrolled at 3 investigative sites in the United States from 10 July 2019 to 31 May 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ublituximab + Umbralisib | Participants were administered ublituximab, 900 milligrams (mg), intravenous (IV) infusion through Cycles 1-6, Cycles 9 and 12. Participants also received umbralisib, 800 mg, oral tablet, daily through Cycles 1-24. 1 Cycle = 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ublituximab + Umbralisib | Participants were administered ublituximab, 900 mg, IV infusion through Cycles 1-6, Cycles 9 and 12. Participants also received umbralisib, 800 mg, oral tablet, daily through Cycles 1-24. 1 Cycle = 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) | ORR was defined as sum of participants with partial responses (PR) and complete responses (CR). CR was defined as complete disappearance of all evidence of disease and disease-related symptoms. PR was defined as regression of measurable disease and no new sites of disease. Regression= ≥ 50% decrease in sum of the products of diameters (SPD) of index lesions, with no unequivocal increase in size of other lymph nodes, liver, or spleen. | Data for this outcome measure was not collected or analyzed as planned as the study was terminated due to sponsor's business decision. | Posted | Up to 22 months |
|
No safety data was collected and analyzed as planned at the end of study
Study was terminated due to sponsor's business decision. Hence, no safety data was collected and analyzed as planned at the end of study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ublituximab + Umbralisib | Participants were administered ublituximab, 900 mg, IV infusion on Days 1, 8, and 15 in Cycle 1 and Day 1 of Cycles 2-6, Cycle 9 and 12. Participants also received umbralisib, 800 mg, oral tablet, daily through Cycles 1-24. 1 Cycle = 28 days. |
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Due to sponsor's business decision, the clinical trial was terminated by the sponsor prematurely. No analysis was done at the termination of the trial, therefore, outcome, and safety data are not available and the numbers of participants analyzed are reported as "0."
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| TG Therapeutics Clinical Support Team | TG Therapeutics | 1-877-575-8489 | clinicalsupport@tgtxinc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2018 | May 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000619007 | ublituximab |
| C000626319 | umbralisib |
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| Umbralisib | Drug | - PI3K Delta Inhibitor oral daily dose |
|
|
| Up to approximately 35 months |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 | An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is an AE that starts or worsens after receiving study drug. | Up to approximately 35 months |
| St. Petersburg |
| Florida |
| 33705 |
| United States |
| TG Therapeutics Investigational Trial Site | Nashville | Tennessee | 37203 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | Progression-Free Survival (PFS) | PFS was defined as the interval from Cycle 1/Day 1 to the earlier of the first documentation of definitive disease progression or death from any cause. Appearance of any new lesion more than 1.5 cm in any axis, even if other lesions were decreasing in size was considered relapsed or progressive disease. At least a 50% increase from nadir in one of the following: SPD of index lesions, greatest transverse diameter (GTD) of any individual previously involved node, or GTD of any previously involved node provided that the GTD of that node was ≥ 1.5 cm. | Data for this outcome measure was not collected or analyzed as planned as the study was terminated due to sponsor's business decision. | Posted | Up to approximately 35 months |
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAE) as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 | An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE is an AE that starts or worsens after receiving study drug. | Data for this outcome measure was not collected or analyzed as planned as the study was terminated due to sponsor's business decision. | Posted | Up to approximately 35 months |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| 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 |