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|Therapy Name||Obinutuzumab + Venetoclax|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Obinutuzumab||Gazyva||R7159|afutuzumab|GA101|GA-101|RO 5072759||CD20 Antibody 11||Gazyva (obinutuzumab) is a glycoengineered anti-CD20 antibody that binds to CD20 on B-cells, resulting in increased antibody-dependent cellular cytotoxicity and induction of apoptosis, and potentially leading to decreased growth of B-cell tumors (PMID: 20194898, PMID: 21220500). Gazyva (obinutuzumab) is FDA approved in combination with Ambochlorin (chlorambucil) for chronic lymphocytic leukemia and in combination with Treanda (bendamustine) or chemotherapy for follicular lymphoma (FDA.gov).|
|Venetoclax||Venclexta||ABT-199|RG7601|GDC-0199|ABT119||BCL2 inhibitor 18||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).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||CLL/SLL||not applicable||Obinutuzumab + Venetoclax||FDA approved||Actionable||In a Phase III trial that supported FDA approval (CLL14), treatment with the combination of Venclexta (venetoclax) and Gazyva (obinutuzumab) resulted in improved progression-free survival (PFS) compared to treatment with Gazyva (obinutuzumab) plus chlorambucil ((HR 0.35; 95% CI 0.23-0.53; P<0.0001) (J Clin Oncol 37, 2019 (suppl; abstr 7502; NCT02242942).||detail... detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|NCT03406156||Phase III||Bendamustine + Obinutuzumab Obinutuzumab + Venetoclax Bendamustine||A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy||Active, not recruiting|
|NCT01685892||Phase I||Obinutuzumab + Venetoclax||A Study of Venetoclax (GDC-0199; ABT-199) in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia||Completed|
|NCT03113422||Phase II||Obinutuzumab Obinutuzumab + Venetoclax Bendamustine + Obinutuzumab + Venetoclax||Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy (PrE0403)||Recruiting|
|NCT04447768||Phase II||Obinutuzumab + Venetoclax||The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL)||Not yet recruiting|
|NCT04285567||Phase III||Obinutuzumab + Venetoclax Bendamustine + Rituximab Cyclophosphamide + Fludarabine + Rituximab||A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation (CRISTALLO)||Recruiting|
|NCT02242942||Phase III||Chlorambucil + Obinutuzumab Obinutuzumab + Venetoclax||A Study to Compare the Efficacy and Safety of Obinutuzumab + GDC-0199 Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia||Active, not recruiting|