Therapy Detail
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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 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). |
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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 |
|---|---|---|---|---|---|---|
| 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 |
| NCT03737955 | Phase II | Gemtuzumab ozogamicin | Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Participants With Acute Myeloid Leukemia | 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 |
| 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 |
| NCT02117297 | Phase II | Gemtuzumab ozogamicin | SCT Plus Immune Therapy in Average Risk AML/MDS | Completed | USA | 0 |
| 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 |
| 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 |
| 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 | IRL | GBR | FRA | CHE | AUS | 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 |
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