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| Therapy Name | Cytarabine + Daunorubicin + Gemtuzumab ozogamicin + Gilteritinib + Hydrocortisone + Methotrexate |
| Synonyms | |
| Therapy Description | |
| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Cytarabine | Cytosar-U | Ara-C | Cytosar-U (cytarabine) is a cytidine analog that, when incorporated into DNA, inhibits DNA synthesis and repair (PMID: 32524309). | |
| Daunorubicin | Cerubidine | Rubidomycin|daunomycin hydrochloride|rubomycin C|Acetyladriamycin | Chemotherapy - Anthracycline 13 | Cerubidine (daunorubicin) is an anthracycline, which inhibits DNA replication and repair. Cerubidine (daunorubicin) is FDA approved for AML and MLL (FDA.gov). |
| Gemtuzumab ozogamicin | Mylotarg | gemtuzumab|CDP-771|CMA-676|WAY-CMA-676 | CD33 Antibody 17 | 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). |
| Gilteritinib | Xospata | ASP2215 | AXL Inhibitor 30 FLT3 Inhibitor 69 | Xospata (gilteritinib) is a small molecule inhibitor of FLT3 and AXL that has activity against FLT3-ITD, FLT3 F691L, and FLT3 D835 mutations, potentially resulting in decreased tumor growth (J Clin Oncol 32:5s, 2014 (suppl; abstr 7070), PMID: 25891481). Xospata (gilteritinib) is FDA approved for use in patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation (ITD, D835X, and I836X) (FDA.gov). |
| Hydrocortisone | Cortisol | |||
| Methotrexate | Abitrexate | Amethopterin | Chemotherapy - Antimetabolite 14 | Methotrexate is an antimetabolite, which inhibits DHFR resulting in decreased immune function and antineoplastic activity and is FDA approved for psoriasis, RA, and several cancers including choriocarcinoma, AML, lung, head and neck and epidermoid (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 |
|---|---|---|---|---|---|---|
| NCT04293562 | Phase III | Cytarabine + Daunorubicin + Hydrocortisone + Methotrexate Cytarabine + Etoposide + Hydrocortisone + Methotrexate Cytarabine + Hydrocortisone + Methotrexate + Mitoxantrone Cytarabine + Daunorubicin + Gemtuzumab ozogamicin + Gilteritinib + Hydrocortisone + Methotrexate Cytarabine + Daunorubicin + Gemtuzumab ozogamicin + Hydrocortisone + Methotrexate Gilteritinib Asparaginase Erwinia chrysanthemi + Cytarabine Cytarabine + Daunorubicin + Gilteritinib + Hydrocortisone + Methotrexate Cytarabine + Etoposide + Gilteritinib + Hydrocortisone + Methotrexate Cytarabine + Gilteritinib + Hydrocortisone + Methotrexate + Mitoxantrone Asparaginase Erwinia chrysanthemi + Cytarabine + Gilteritinib | A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations | Recruiting | USA | CAN | AUS | 1 |