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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 12||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|
|TP53 loss||CLL/SLL||sensitive||Obinutuzumab + Venetoclax||Guideline||Actionable||The combination of Venclexta (venetoclax) and Gazyva (obinutuzumab) is indicated in the guidelines as first line therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with TP53 loss (NCCN.org).||detail...|
|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 0.31; 95% CI 0.22-0.44; P<0.0001) in patients with previously untreated chronic lymphocytic leukemia (PMID: 32888452; NCT02242942).||32888452 detail...|
|TP53 mutant||CLL/SLL||sensitive||Obinutuzumab + Venetoclax||Guideline||Actionable||The combination of Venclexta (venetoclax) and Gazyva (obinutuzumab) is indicated in the guidelines as first line therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma patients with a TP53 mutation (NCCN.org).||detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|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||USA||4|
|NCT04447768||Phase II||Obinutuzumab + Venetoclax||The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL)||Recruiting||USA||0|
|NCT04560322||Phase II||Obinutuzumab + Venetoclax Ibrutinib + Obinutuzumab + Venetoclax||Venetoclax-Obinutuzumab +/- Ibrut in R/R CLL||Not yet recruiting||USA||0|
|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||USA||0|
|NCT01685892||Phase I||Obinutuzumab + Venetoclax||A Study of Venetoclax (GDC-0199; ABT-199) in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia||Completed||USA||1|
|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||USA | CAN||19|
|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)||Active, not recruiting||USA||0|
|NCT04269902||Phase III||Obinutuzumab + Venetoclax||Testing the Effects of Early Treatment With Venetoclax and Obinutuzumab Versus Delayed Treatment With Venetoclax and Obinutuzumab for Newly Diagnosed Patients With High-Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Who Do Not Have Symptoms, the EVOLVE CLL/SLL Study||Recruiting||USA||0|