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Therapy Name Gemtuzumab ozogamicin
Synonyms
Therapy Description

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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
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).

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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
NCT03672539 Phase I Gemtuzumab ozogamicin CPX-351 + Gemtuzumab ozogamicin Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome Recruiting USA 0
NCT01869803 Phase I Gemtuzumab ozogamicin Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia Approved for marketing USA 0
NCT03374332 Phase II Gemtuzumab ozogamicin Infusional Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Refractory Acute Myeloid Leukemia Active, not recruiting USA 0
NCT05662904 Phase I Gemtuzumab ozogamicin Genetic Ablation of CD33 in HSC to Broaden the Therapeutic Index of CD33-directed Immunotherapy in Patients With AML (GALAXY33) Not yet recruiting DEU 0
NCT02724163 Phase III Gemtuzumab ozogamicin Busulfan + Fludarabine Cytarabine Cytarabine + Fludarabine Cytarabine + Daunoxome Busulfan + Cyclophosphamide Cytarabine + Mitoxantrone International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia (Myechild01) Recruiting NZL | GBR | FRA | AUS 2
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
NCT04050280 Phase II Cladribine + Cytarabine + Filgrastim + Gemtuzumab ozogamicin Gemtuzumab ozogamicin Cladribine + Cytarabine + Filgrastim CLAG-GO for Patients With Persistent, Relapsed or Refractory AML Recruiting USA 0
NCT03737955 Phase II Gemtuzumab ozogamicin Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Participants With Acute Myeloid Leukemia Recruiting USA 0
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
NCT02117297 Phase II Gemtuzumab ozogamicin SCT Plus Immune Therapy in Average Risk AML/MDS Completed USA 0


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