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Therapy Name | Gemtuzumab ozogamicin + Glasdegib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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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). |
Glasdegib | Daurismo | PF-04449913 | SMO Inhibitor 16 | Daurismo (glasdegib) inhibits Smoothened (SMO), resulting in decreased Hedgehog (Hh) pathway signalling, and potentially inhibiting Hh-mediated tumor growth (PMID: 24900436, PMID: 25388167). Daurismo (glasdegib) is FDA approved for use in combination with low-dose cytarabine in patients 75 years old or older with newly-diagnosed acute myeloid leukemia (FDA.gov). |
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 |
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NCT04168502 | Phase III | Gemtuzumab ozogamicin + Glasdegib Gemtuzumab ozogamicin | Gemtuzumab Chemotherapy MRD Levels; Glasdegib Post-transplant, Adult Untreated, de Novo, Fav Interm Risk AML | Recruiting | ITA | 0 |
NCT04093505 | Phase III | Gemtuzumab ozogamicin + Glasdegib Gemtuzumab ozogamicin | Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia) (GnG) | Terminated | DEU | 0 |
NCT03390296 | Phase II | Avelumab + Azacitidine + PF-04518600 Azacitidine + PF-04518600 Avelumab + Utomilumab Avelumab + Glasdegib Gemtuzumab ozogamicin + Glasdegib PF-04518600 Avelumab + PF-04518600 PF-04518600 + Utomilumab | Pfizer Immunotherapy Combinations for Acute Myeloid Leukemia (AML) Multi-Arm Study 1 | Completed | USA | 0 |