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Therapy Name | Obinutuzumab + Venetoclax |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Obinutuzumab | Gazyva | R7159|afutuzumab|GA101|GA-101|RO 5072759 | CD20 Antibody 24 | 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). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
TP53 mutant | chronic lymphocytic leukemia | sensitive | Obinutuzumab + Venetoclax | Guideline | Actionable | Venclexta (venetoclax) and Gazyva (obinutuzumab) combination therapy is included in guidelines as first-line therapy for patients with advanced chronic lymphocytic leukemia harboring TP53 mutations and for patients with relapsed or refractory disease (PMID: 38969011; ESMO.org). | 38969011 detail... |
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... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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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 | SWE | NOR | NLD | ITA | ISR | IRL | FIN | ESP | DNK | DEU | CHE | BEL | AUT | 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 |
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 |
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 |
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 |
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) | Active, not recruiting | USA | POL | HUN | FRA | ESP | CZE | AUS | 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 | ROU | POL | NZL | ITA | HRV | GBR | FRA | EST | ESP | DNK | DEU | CHE | CAN | BRA | BGR | AUT | AUS | ARG | 2 |
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 | TUR | SWE | POL | NZL | NLD | ITA | ISR | GBR | FRA | ESP | DEU | CZE | CAN | BRA | AUT | AUS | 3 |
NCT04560322 | Phase II | Obinutuzumab + Venetoclax Ibrutinib + Obinutuzumab + Venetoclax | Venetoclax-Obinutuzumab +/- Ibrut in R/R CLL | Recruiting | USA | 0 |
NCT04073147 | Phase I | Obinutuzumab + Venetoclax | Venetoclax and Obinutuzumab for Relapsed/Refractory Primary CNS Lymphoma (VENOBI-CNS) | Terminated | DEU | 0 |
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 |
NCT06428019 | Phase III | Obinutuzumab + Venetoclax Acalabrutinib + Venetoclax | A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL) | Recruiting | USA | 1 |
NCT04447768 | Phase II | Obinutuzumab + Venetoclax | The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL) | Active, not recruiting | USA | 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 | ROU | ITA | ISR | GBR | ESP | DEU | BRA | BGR | AUT | AUS | 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 |
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 |