Therapy Detail

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Therapy Name Obinutuzumab + Venetoclax
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Obinutuzumab Gazyva R7159|afutuzumab|GA101|GA-101|RO 5072759 CD20 Antibody 21 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|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
TP53 loss chronic lymphocytic leukemia/small lymphocytic lymphoma 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...
TP53 mutant chronic lymphocytic leukemia/small lymphocytic lymphoma 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...
TP53 mutant chronic lymphocytic leukemia sensitive Obinutuzumab + Venetoclax Guideline Actionable Venclexta (venetoclax) and Gazyva (obinutuzumab) combination therapy is included in the guidelines as first-line therapy for patients with advanced chronic lymphocytic leukemia harboring TP53 mutations and for patients with relapsed or refractory disease (PMID: 33091559; ESMO.org). 33091559 detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05057494 Phase III Obinutuzumab + Venetoclax Acalabrutinib + Venetoclax A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (MAJIC) Recruiting USA | FRA | ESP | AUS 3
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 Completed 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 | GBR 0
NCT04073147 Phase I Obinutuzumab + Venetoclax Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma (VENOBI-CNS) Terminated DEU 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 | CAN 0
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 | NZL | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS 11
NCT04560322 Phase II Obinutuzumab + Venetoclax Ibrutinib + Obinutuzumab + Venetoclax Venetoclax-Obinutuzumab +/- Ibrut in R/R CLL Recruiting USA 0
NCT05197192 Phase III Obinutuzumab + Venetoclax Acalabrutinib + Obinutuzumab + Venetoclax A Prospective, Open-label, Multicentre, Randomized, Phase-3-trial of Acalabrutinib, Obinutuzumab and Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk Chronic Lymphatic Leukemia Recruiting DEU 0
NCT04447768 Phase II Obinutuzumab + Venetoclax The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL) Recruiting USA 0
NCT06073821 Phase III Obinutuzumab + Venetoclax BGB-11417 + Zanubrutinib Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL) Recruiting USA | NZL | CAN | AUS 0
NCT04608318 Phase III Ibrutinib Ibrutinib + Venetoclax Obinutuzumab + Venetoclax Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) (CLL17) Active, not recruiting NLD | ITA | ESP | DEU | BEL | AUT 7
NCT05478512 Phase II Obinutuzumab + Venetoclax + Zanubrutinib Obinutuzumab + Venetoclax Front-line VenObi Combination Followed by Ven or VenZan Combination in Patients With Residual Disease: a MRD Tailored Treatment for Young Patients With High-risk CLL (VIS) Recruiting ITA 0
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) Completed USA 0
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) Active, not recruiting USA | ITA | FRA | ESP | AUS 0
NCT04895436 Phase II Obinutuzumab + Venetoclax Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL) Recruiting USA | ITA | ESP | DEU | AUT | AUS 4


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