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|Therapy Name||Ublituximab + Umbralisib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Ublituximab||LFB-R603|TG-1101|TG-20|TGTX-1101||CD20 Antibody 12||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 25||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).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT04149821||Phase II||Ublituximab + Umbralisib||Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy||Recruiting||USA||0|
|NCT04508647||Phase II||Ublituximab Ublituximab + Umbralisib||Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma||Recruiting||USA||0|
|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||Enrolling by invitation||USA||3|
|NCT03828448||Phase II||Ublituximab + Umbralisib||Study to Assess Umbralisib Plus Ublituximab in Patients With Treatment Naive Follicular Lymphoma||Recruiting||USA||0|
|NCT02006485||Phase I||Ublituximab + Umbralisib Ibrutinib||Ublituximab in Combination With TGR-1202 in Patients With B-cell Malignancies||Completed||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)||Active, not recruiting||USA||8|
|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||Enrolling by invitation||USA||0|