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|Therapy Name||Azacitidine + Cytarabine + Fludarabine + Gemtuzumab ozogamicin|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|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).|
|Cytarabine||Cytosar-U||Ara-C||Cytosar-U (cytarabine) is a cytidine analog that, when incorporated into DNA, inhibits DNA synthesis and repair (PMID: 32524309).|
|Fludarabine||Fludara||FAMP|Fludarabine phosphate||Flurdara (fludarabine) is converted to 2-fluoro-ara-ATP intracellularly, which potentially inhibits DNA polymerase alpha, ribonucleotide reductase and DNA primase, leading to decreased DNA synthesis and reduced tumor growth (NCI Drug Dictionary)|
|Gemtuzumab ozogamicin||Mylotarg||gemtuzumab|CDP-771|CMA-676|WAY-CMA-676||CD33 Antibody 11||Mylotarg (gemtuzumab ozogamicin) is an antibody-drug conjugate comprising an anti-CD33 antibody linked to the cytotoxic agent calicheamicin, which results in DNA damage in CD33-expressing tumor cells (PMID: 28607471). Mylotarg (gemtuzumab ozogamicin) is FDA approved for newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adult and pediatric patients 1 month and older, and in relapsed or refractory CD33-positive AML in adult and pediatric patients 2 years and older (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT05183035||Phase III||Azacitidine + Cytarabine + Fludarabine + Gemtuzumab ozogamicin + Venetoclax Azacitidine + Cytarabine + Fludarabine + Gemtuzumab ozogamicin||Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)||Recruiting||USA||0|