{"entity":{"id":"nct03591510","kind":"trial","name":"A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML","aka":[],"tldr":"A phase 2 trial of Midostaurin, Fludarabine, Cytarabine, Daunorubicin, Idarubicin and Mitoxantrone in acute myeloid leukaemia, run by Novartis Pharmaceuticals, active and no longer recruiting.","summary":"A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML is a phase 2 interventional study registered as NCT03591510 by Novartis Pharmaceuticals, with 22 participants enrolled, started 2019-03-13 and due to reach its primary completion in 2029-05-18. Interventions recorded: Midostaurin, Fludarabine, Cytarabine, Daunorubicin or idarubicin, Mitoxantrone and Etoposide.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03591510","url":"https://clinicaltrials.gov/study/NCT03591510"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-paediatric"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["midostaurin","fludarabine","cytarabine","daunorubicin","idarubicin","mitoxantrone"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03591510","phase":"2","setting":"A Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin (PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutated AML","sponsor":"Novartis Pharmaceuticals","started":"2019-03-13","startedType":"actual","enrolled":22,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct03591510/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-paediatric","kind":"cancer","name":"Acute myeloid leukaemia in children","route":"/cancers/aml-paediatric/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"cytarabine","kind":"drug","name":"Cytarabine","route":"/drugs/cytarabine/"},{"id":"daunorubicin","kind":"drug","name":"Daunorubicin","route":"/drugs/daunorubicin/"},{"id":"fludarabine","kind":"drug","name":"Fludarabine","route":"/drugs/fludarabine/"},{"id":"idarubicin","kind":"drug","name":"Idarubicin","route":"/drugs/idarubicin/"},{"id":"midostaurin","kind":"drug","name":"Midostaurin","route":"/drugs/midostaurin/"},{"id":"mitoxantrone","kind":"drug","name":"Mitoxantrone","route":"/drugs/mitoxantrone/"}],"company":[{"id":"advanced-accelerator-applications","kind":"company","name":"Advanced Accelerator Applications (Novartis)","route":"/companies/advanced-accelerator-applications/"},{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}]}}