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|Therapy Name||Busulfan + Cyclophosphamide + Gemtuzumab ozogamicin|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Busulfan||Busulfex||Busulphan||Busulfex (busulfan) inhibits DNA replication and RNA transcription, likely through induction of DNA alkylation (PMID: 27481448). Busulfex (busulfan) in combination with cyclophosphamide is FDA approved as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for patients with chronic myelogenous leukemia (FDA.gov).|
|Cyclophosphamide||Cytoxan||CPM||Chemotherapy - Alkylating 16||Cytoxan (cyclophosphamide) is an alkylating agent, which inhibits DNA replication (NCI Drug Dictionary). Cytoxan (cyclophosphamide) is FDA approved in multiple hematological malignancies, breast cancer, neuroblastoma, ovarian cancer, and retinoblastoma (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|
|NCT02221310||Phase II||Busulfan + Cyclophosphamide + Gemtuzumab ozogamicin||Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS||Active, not recruiting||USA||0|