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Therapy Detail

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Therapy Name Arsenic trioxide + Gemtuzumab ozogamicin + Tretinoin
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Arsenic trioxide Trisenox ATO GLI1/2 inhibitor 6 Trisenox (arsenic trioxide) has multiple mechanisms of action, including inhibition of Gli1 and Gli2 transcription factors (PMID: 26891329). Trisenox (arsenic trioxide) is FDA approved for patients with acute promyelocytic leukemia with PML-RARA translocations (FDA.gov).
Gemtuzumab ozogamicin Mylotarg gemtuzumab|CDP-771|CMA-676|WAY-CMA-676 CD33 Antibody 16 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).
Tretinoin Vesanoid Aberel|Aknoten|Avita|Renova|Retin-A|all-trans retinoic acid|Vitamin A Acid|ATRA Vesanoid (tretinoin) is a form of retinoic acid, which binds to retinoic acid receptors and activates downstream signaling, potentially inducing cell differentiation and subsequently, apoptosis (PMID: 11704842). Vesanoid (tretinoin) is FDA approved for patients with acute promyelocytic leukemia harboring PML-RARA (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
NCT01409161 Phase II Arsenic trioxide + Gemtuzumab ozogamicin + Tretinoin Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia Recruiting USA 0
NCT04793919 Phase II Arsenic trioxide + Gemtuzumab ozogamicin + Tretinoin Arsenic trioxide + Tretinoin Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia Recruiting SWE | NLD | ITA | ISR | IRL | FRA | ESP | DNK | DEU | CZE | BEL 1
NCT02339740 Phase III Cytarabine + Dexamethasone + Idarubicin + Mitoxantrone Arsenic trioxide + Gemtuzumab ozogamicin + Tretinoin Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia Active, not recruiting USA | NZL | CAN | AUS 2


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