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|Therapy Name||Cladribine + Cytarabine + Filgrastim + Gemtuzumab ozogamicin + Mitoxantrone|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Cladribine||Leustatin||2-CdA||Leustatin (cladribine) is a purine analog that is incorporated into DNA, resulting in DNA single strand breaks and apoptosis (NCI Drug Dictionary).|
|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).|
|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).|
|Mitoxantrone||Novantrone||CL 232315||Novantrone (Mitoxantrone) binds to and inhibits topoisomerase II, leading to DNA double strand breaks and decreased DNA repair (NCI Drug Dictionary).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|NCT03531918||Phase Ib/II||Cladribine + Cytarabine + Filgrastim + Gemtuzumab ozogamicin + Mitoxantrone Cladribine + Cytarabine + Filgrastim||Gemtuzumab Ozogamicin With G-CSF, Cladribine, Cytarabine and Mitoxantrone in Treating Participants With Previously Untreated Acute Myeloid Leukemia or High-Grade Myeloid Neoplasm||Recruiting|