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|Therapy Name||Ublituximab + Umbralisib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Ublituximab||LFB-R603|TG-1101||Ublituximab 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).|
|Umbralisib||RP5264|TGR-1202||PIK3CD inhibitor 25||Umbralisib (TGR-1202) is a selective inhibitor of PIK3CD, which prevents Akt phosphorylation and induces cytotoxicity (J Clin Oncol 32:5s, 2014 (suppl; abstr 2513), PMID: 30709431).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||follicular lymphoma||not applicable||Ublituximab + Umbralisib||Phase I||Actionable||In a Phase I trial, high-dose TGR-1202 in combination with Ublituximab resulted in complete response in 17% (1/6) and partial response in 33% (2/6) of patients with follicular lymphoma (J Clin Oncol 33, 2015 (suppl; abstr 8548)).||detail...|
|Unknown unknown||chronic lymphocytic leukemia||not applicable||Ublituximab + Umbralisib||Phase I||Actionable||In a Phase I trial, TGR-1202 and Ublituximab combination treatment resulted in a median progression-free survival of 8 months in all 10 chronic lymphocytic leukemia patients, with partial response in 100% (3/3) of patients in the high-dose TGR-1201 group and 57% (4/7) in the low-dose group (J Clin Oncol 33, 2015 (suppl; abstr 8548)).||detail...|
|Unknown unknown||diffuse large B-cell lymphoma||not applicable||Ublituximab + Umbralisib||Phase I||Actionable||In a Phase I trial, high-dose TGR-1202 in combination with Ublituximab resulted in complete response in 50% (2/4) and partial response in 25% (1/4) of patients with diffuse large B-cell lymphoma (J Clin Oncol 33, 2015 (suppl; abstr 8548)).||detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|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)||Recruiting|
|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|
|NCT02006485||Phase I||Ublituximab + Umbralisib Ibrutinib||Ublituximab in Combination With TGR-1202 in Patients With B-cell Malignancies||Completed|
|NCT04149821||Phase II||Ublituximab + Umbralisib||Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy||Recruiting|
|NCT03828448||Phase II||Ublituximab + Umbralisib||Study to Assess Umbralisib Plus Ublituximab in Patients With Treatment Naive Follicular Lymphoma||Recruiting|
|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|