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Therapy Name Cytarabine + Filgrastim + Fludarabine + Gemtuzumab ozogamicin + Idarubicin
Synonyms
Therapy Description

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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 12 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).

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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
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


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