{"entity":{"id":"nct04293562","kind":"trial","name":"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","aka":[],"tldr":"A phase 3 trial of Crisantaspase, Asparaginase, Cytarabine, Daunorubicin, Dexrazoxane, Etoposide, Fludeoxyglucose F-18, Gemtuzumab ozogamicin, Gilteritinib, CPX-351, Methotrexate and Mitoxantrone in Acute myeloid leukaemia, run by Children's Oncology Group, now recruiting.","summary":"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 is a phase 3 interventional study registered as NCT04293562 by Children's Oncology Group, with 1400 participants planned, started 2020-07-21 and due to reach its primary completion in 2029-06-30. Interventions recorded: Allogeneic Hematopoietic Stem Cell Transplantation, Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cytarabine, Daunorubicin Hydrochloride, Dexrazoxane Hydrochloride, Etoposide, Fludeoxyglucose F-18, Gemtuzumab Ozogamicin, Gilteritinib Fumarate, Liposome-encapsulated Daunorubicin-Cytarabine, Magnetic Resonance Imaging, Methotrexate, Mitoxantrone Hydrochloride, Positron Emission Tomography, Questionnaire Administration, Therapeutic Hydrocortisone. Conditions recorded: Acute Myeloid Leukemia.\n\nLinked to the drug Crisantaspase because the registry names it among its interventions and Acute myeloid leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"recruiting","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04293562","url":"https://clinicaltrials.gov/study/NCT04293562"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml"],"sections":[],"technologies":[],"targets":[],"drugs":["crisantaspase","asparaginase","cytarabine","daunorubicin","dexrazoxane","etoposide","fludeoxyglucose-f18","gemtuzumab-ozogamicin","gilteritinib","cpx-351","methotrexate","mitoxantrone"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04293562","phase":"3","setting":"A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations","sponsor":"Children's Oncology Group","enrolled":1400,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04293562/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"}],"drug":[{"id":"asparaginase","kind":"drug","name":"Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase)","route":"/drugs/asparaginase/"},{"id":"cpx-351","kind":"drug","name":"CPX-351 (liposomal daunorubicin-cytarabine)","route":"/drugs/cpx-351/"},{"id":"crisantaspase","kind":"drug","name":"Crisantaspase (recombinant Erwinia asparaginase)","route":"/drugs/crisantaspase/"},{"id":"cytarabine","kind":"drug","name":"Cytarabine","route":"/drugs/cytarabine/"},{"id":"daunorubicin","kind":"drug","name":"Daunorubicin","route":"/drugs/daunorubicin/"},{"id":"dexrazoxane","kind":"drug","name":"Dexrazoxane","route":"/drugs/dexrazoxane/"},{"id":"etoposide","kind":"drug","name":"Etoposide","route":"/drugs/etoposide/"},{"id":"fludeoxyglucose-f18","kind":"drug","name":"Fludeoxyglucose F-18 (FDG)","route":"/drugs/fludeoxyglucose-f18/"},{"id":"gemtuzumab-ozogamicin","kind":"drug","name":"Gemtuzumab ozogamicin","route":"/drugs/gemtuzumab-ozogamicin/"},{"id":"gilteritinib","kind":"drug","name":"Gilteritinib","route":"/drugs/gilteritinib/"},{"id":"methotrexate","kind":"drug","name":"Methotrexate","route":"/drugs/methotrexate/"},{"id":"mitoxantrone","kind":"drug","name":"Mitoxantrone","route":"/drugs/mitoxantrone/"}]}}