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Therapy Name | Azacitidine + Enasidenib |
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). |
Enasidenib | Idhifa | AG-221 | IDH2 Inhibitor 2 | Idhifa (enasidenib) inhibits IDH2 to prevent 2HG formation, which may promote differentiation and inhibit proliferation of cancer cells (PMID: 28280273). Idhifa (enasidenib) is FDA-approved for use in patients with relapsed or refractory acute myeloid leukemia harboring an IDH2 mutation (R140Q/L/G/W, R172K/M/G/S/W) (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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NCT03683433 | Phase II | Azacitidine + Enasidenib | Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation | Recruiting | USA | 0 |
NCT02677922 | Phase Ib/II | Azacitidine + Ivosidenib Azacitidine Azacitidine + Enasidenib | A Safety and Efficacy Study of Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus Subcutaneous Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) | Active, not recruiting | USA | CAN | 10 |
NCT03383575 | Phase II | Azacitidine + Enasidenib Enasidenib | Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome | Recruiting | USA | 0 |
NCT03013998 | Phase Ib/II | Azacitidine + Enasidenib Azacitidine + Entospletinib Cytarabine + Daunorubicin + Samalizumab Azacitidine + BI 836858 | Study of Biomarker-Based Treatment of Acute Myeloid Leukemia | Recruiting | USA | 0 |