Therapy Detail
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| Therapy Name | Ublituximab + Umbralisib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Ublituximab | LFB-R603|TG-1101|TG-20|TGTX-1101 | CD20 Antibody 24 | Ublituximab (TG-1101) is a monoclonal antibody that targets CD20 that may induce complement-dependent and antibody-dependent cell-mediated cytotoxicity against B-cells expressing CD20, potentially resulting in increased B-cell death (PMID: 23611989, PMID: 32351164). | |
| Umbralisib | Ukoniq | RP5264|TGR-1202 | PIK3CD inhibitor 27 | Ukoniq (umbralisib) is a selective inhibitor of PIK3CD, which prevents Akt phosphorylation and induces cytotoxicity (J Clin Oncol 32:5s, 2014 (suppl; abstr 2513), PMID: 30709431). Ukoniq (umbralisib) is FDA approved for use in adult patients with relapsed or refractory marginal zone lymphoma with one or more prior anti-CD20-based therapy, and in adult patients with relapsed or refractory follicular lymphoma who have three or more prior lines of therapy (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03828448 | Phase II | Ublituximab + Umbralisib | Study to Assess Umbralisib Plus Ublituximab in Patients With Treatment Naive Follicular Lymphoma | Terminated | USA | 0 |
| NCT04149821 | Phase II | Ublituximab + Umbralisib | Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy | Terminated | USA | 0 |
| NCT03207256 | Phase II | Ublituximab + Umbralisib Umbralisib | Compassionate Use Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials | Terminated | USA | 0 |
| NCT02793583 | Phase II | Umbralisib Ublituximab + Umbralisib | Study to Assess the Efficacy and Safety of Ublituximab + TGR-1202 and TGR-1202 Alone in Patients With Previously Treated Diffuse Large B-Cell Lymphoma (UNITY-DLBCL) | Terminated | USA | SVK | POL | ITA | ISR | GBR | ESP | AUS | 1 |
| NCT02656303 | Phase II | Ublituximab + Umbralisib | An Open-Label Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304 | Terminated | USA | POL | ITA | GBR | 0 |
| NCT04508647 | Phase II | Ublituximab Ublituximab + Umbralisib | Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma | Completed | USA | 0 |
| NCT02006485 | Phase I | Ublituximab + Umbralisib Ibrutinib | Ublituximab in Combination With TGR-1202 in Patients With B-cell Malignancies | Completed | USA | 0 |
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