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Therapy Name | Azacitidine + Hu5F9-G4 + Venetoclax |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Azacitidine | Vidaza | azacytidine|CC-486|5-azacytidine|5-AC|U-18496|Onureg | DNMT inhibitor (Pan) 5 | Vidaza (azacitidine) is a cytidine analog that incorporates into DNA and RNA and binds to DNA methyltransferases (DNMTs), resulting in DNMT degradation and decreased DNA methylation, and leading to increased tumor cell death (PMID: 28159832, PMID: 28067760). Vidaza (azacitidine) is FDA-approved for use in patients with some subtypes of myelodysplastic syndrome and Onureg (azacitidine) is FDA approved for use in continued treatment of acute myeloid leukemia(FDA.gov). |
Hu5F9-G4 | Magrolimab|Hu5F9 G4|GS-4721 | CD47 Antibody 31 Immune Checkpoint Inhibitor 149 | Magrolimab (Hu5F9-G4) is a humanized monoclonal antibody against CD47 that binds to and blocks CD47 downstream signaling and subsequent activation of the SIRPa receptor on macrophages, leading to phagocytosis of tumor cells (PMID: 26390038, PMID: 28286286) and may also stimulate cytotoxic T-cells (PMID: 29873856). | |
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 |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT05079230 | Phase III | Azacitidine + Hu5F9-G4 + Venetoclax Azacitidine + Venetoclax | Study Evaluating the Safety and Effectiveness Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia (AML) (ENHANCE-3) | Terminated | USA | POL | NOR | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BEL | AUT | AUS | 3 |
NCT04435691 | Phase Ib/II | Azacitidine + Hu5F9-G4 + Venetoclax | Magrolimab, Azacitidine, and Venetoclax for the Treatment of Acute Myeloid Leukemia | Active, not recruiting | USA | 0 |
NCT04778410 | Phase II | Azacitidine + Hu5F9-G4 + Venetoclax Cytarabine + Etoposide + Hu5F9-G4 + Mitoxantrone Azacitidine + Hu5F9-G4 | Study of Magrolimab Combinations in Participants With Myeloid Malignancies | Completed | USA | GBR | AUS | 0 |