protocolSection identificationModule nctId: NCT06262438, orgStudyIdInfo id: MH22CAQ, secondaryIdInfos id: 2022-002886-14, type: EUDRACT_NUMBER, secondaryIdInfos id: 2023-505000-27, type: OTHER, domain: EU CT Number, briefTitle: CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients, acronym: CHIP-AML22/Q, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2032-06, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Princess Maxima Center for Pediatric Oncology, class: OTHER, collaborators name: Daiichi Sankyo, descriptionModule briefSummary: The CHIP-AML22 Master protocol has the overall aim of increasing the cure rate in newly diagnosed pediatric de novo AML patients, while avoiding unnecessary toxicity. The linked Quizartinib trial (CHIP-AML22/Quizartinib) is a phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric AML patients with a FLT3-ITD mutation and NPM1 wild-type., conditionsModule conditions: Acute Myeloid Leukemia in Children, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Given the rarity of pediatric subjects with newly diagnosed Acute Myeloid Leukemia (AML) with FLT3-ITD mutations and the slow enrollment in historical studies, it is not feasible to enroll a sufficient number of subjects for an adequately powered randomized study. Therefore, a standard oncology Phase 2 response-rate design has been chosen. One of the exploratory objectives planned is to compare the outcome of patients treated in this study to the outcome of patients treated in the NOPHO-DBH AML-2012 study as historical control., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Quizartinib, interventions name: Etoposide, interventions name: Dexrazoxane, interventions name: Mitoxantrone, interventions name: Cytarabine, interventions name: Methotrexate, interventions name: Daunorubicin, interventions name: Fludarabine, interventions name: allo-SCT, outcomesModule primaryOutcomes measure: Primary objective (efficacy), primaryOutcomes measure: Primary objective (safety), secondaryOutcomes measure: Secondary objectives (efficacy_1), secondaryOutcomes measure: Secondary objectives (efficacy_2), secondaryOutcomes measure: Secondary objectives (efficacy_3), secondaryOutcomes measure: Secondary objectives (efficacy_4), secondaryOutcomes measure: Secondary objectives (efficacy_5), secondaryOutcomes measure: Secondary objectives (efficacy_6), secondaryOutcomes measure: Secondary objectives (efficacy_7), secondaryOutcomes measure: Secondary objectives (efficacy_8), secondaryOutcomes measure: Secondary objectives (efficacy_9), secondaryOutcomes measure: Secondary objectives (safety) - Adverse Events, Laboratory Abnormalities and cumulative incidence of non-relapse mortality, secondaryOutcomes measure: Pharmacokinetics (PK_1), secondaryOutcomes measure: Pharmacokinetics (PK_2), secondaryOutcomes measure: Pharmacokinetics (PK_3), secondaryOutcomes measure: Pharmacokinetics (PK_4), secondaryOutcomes measure: Palatability of quizartinib formulations, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Princess Máxima Center for pediatric oncology, status: RECRUITING, city: Utrecht, zip: 3584 CS, country: Netherlands, contacts name: Gertjan Kaspers, Prof. Dr., role: CONTACT, contacts name: Bianca Goemans, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False