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|Therapy Name||Cytarabine + Filgrastim + Fludarabine + Gemtuzumab ozogamicin + Idarubicin|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Cytarabine||Cytosar-U||Ara-C||Cytosar-U (cytarabine) is a cytidine analog that, when incorporated into DNA, inhibits DNA synthesis and repair (PMID: 32524309).|
|Filgrastim||Neupogen||G-CSF||Neupogen (filgrastim) is a recombinant analog of granulocyte colony-stimulating factor (G-CSF) isoform B, which binds and activates G-CSF receptors modulating neutrophilic granulocyte progenitor activity, production, and differentiation (NCI Drug Dictionary).|
|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).|
|Idarubicin||Idamycin||Idarubicin Hcl||Chemotherapy - Anthracycline 13||Idarubicin is an anthracycline, which inhibits DNA replication thereby preventing RNA and protein synthesis and, in combination with other approved drugs, is FDA approved for acute myelogenous leukemia (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|
|NCT00801489||Phase II||Cytarabine + Filgrastim + Fludarabine + Gemtuzumab ozogamicin Cytarabine + Filgrastim + Fludarabine + Gemtuzumab ozogamicin + Idarubicin||Fludarabine, Cytarabine, Filgrastim, Gemtuzumab Ozogamicin, and Idarubicin in Core Binding Factor (CBF) Leukemias||Recruiting||USA||0|