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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 13 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 Idamycin (idarubicin) is an anthracycline that inhibits DNA replication thereby preventing RNA and protein synthesis, which may lead to tumor growth inhibition (PMID: 2192943). Idamycin (idarubicin) 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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