Therapy Detail

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Therapy Name Ublituximab + Umbralisib + Venetoclax
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 21 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).
Venetoclax Venclexta ABT-199|RG7601|GDC-0199|ABT119|Venclyxto BCL2 inhibitor 27 Venclexta (venetoclax) is a BH3-mimetic that binds to and inhibits BCL2, resulting in increased tumor cell apoptosis (PMID: 26589495, PMID: 25048785). Venclexta (venetoclax) is FDA approved for use in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination with chemotherapy in patients 75 years old or older with newly-diagnosed acute myeloid leukemia (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
NCT03379051 Phase Ib/II Ublituximab + Umbralisib + Venetoclax Venetoclax in Combination With Ublituximab and Umbralisib (TGR-1202) in Patients With Relapsed or Refractory CLL/SLL Terminated USA 0
NCT04016805 Phase II Ublituximab + Umbralisib + Venetoclax Ibrutinib + Ublituximab + Umbralisib Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Subjects With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib or Venetoclax Terminated USA 0
NCT03801525 Phase II Ublituximab + Umbralisib + Venetoclax Study to Assess the Efficacy and Safety of Ublituximab Plus Umbralisib in Combination With Venetoclax in Subjects With CLL (ULTRA-V) Terminated USA 0


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