[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia-in-children":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,72,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100500111","study-of-the-medullary-microenvironment-in-acute-childhood-leukemia-100500111",false,"NCT05792007","Study of the Medullary Microenvironment in Acute Childhood Leukemia","Etude du Microenvironnement médullaire Dans Les Leucémies Aiguës de l'Enfant","MILA","Inclusion Criteria:\n\n* for patients with AL:\n\n  1. Child with acute lymphoblastic or myeloblastic leukemia at diagnosis\n  2. Not having received prior hematological treatment\n  3. Aged 1 to 15 years old\n  4. Whose 2 parents, or the holder of parental authority, have signed a consent enlightened.\n  5. Affiliated patient or beneficiary of a social security scheme.\n* Control group patients:\n\n  1. Child undergoing orthopedic surgery exposing the bone marrow (osteotomy of the pelvis).\n  2. Aged between 1 and 15 years old.\n  3. Having no pathology of hematological origin.\n  4. Not having received any treatment that could interfere with the functioning of the bone marrow.\n  5. Whose 2 parents or the holder of parental authority have signed a consent enlightened.\n  6. Affiliated patient or beneficiary of a social security scheme.\n\nExclusion Criteria:\n\n* for patients with AL:\n\n  1. Patient under 1 year old and over 15 years old.\n  2. Contraindication to myelogram.\n  3. Absence of signature of the informed consent by the 2 parents or the holder of parental authority.\n  4. Patients with relapsed acute lymphoblastic or myeloblastic leukemia.\n  5. Having received prior hematological treatments.\n  6. Parents with physical or mental condition not allowing to understand the informed consent.\n* Control group patients\n\n  1. Patient under 1 year old and over 15 years old.\n  2. Having an underlying haematological pathology.\n  3. Absence of signature of the informed consent by the 2 parents or the holder of parental authority.\n  4. Having received prior hematological treatments.\n  5. Parents with physical or mental condition not allowing to understand informed consent.",true,"ALL","1 Year","15 Years",{"count":22,"type":23},40,"ESTIMATED","INTERVENTIONAL",[26],"NA","Acute leukemia (AL) is the most common cancer in children. Despite the optimization of chemotherapy treatments and the development of supportive care, a certain number of LAs relapse and\u002For progress to death of the child. It therefore seems essential to try to better understand the physiopathology and the mechanisms of resistance to treatment of these diseases.",[29,30],"Acute Lymphoid Leukemia","Acute Myeloid Leukemia in Children","RECRUITING","2025-11-18",{"date":34,"type":35},"2025-11-24","ACTUAL",{"date":37,"type":35},"2023-10-26",{"date":39,"type":23},"2028-10-24",{"name":41,"class":42},"University Hospital, Tours","OTHER",3,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":24,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100536254","phase-2-chip-aml22quizartinib-quizartinib--chemotherapy-in-newly-diagnosed-pediatric-flt3-itd-and-npm1wt-aml-patients-100536254","NCT06262438","CHIP-AML22\u002FQuizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients","A Phase II, Single Arm, Open Label, Study on the Safety, Efficacy, Pharmacokinetics & Pharmacodynamics of Quizartinib + Chemotherapy and as Single-agent After High Dose Therapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients","CHIP-AML22\u002FQ","Inclusion criteria:\n\n1. Enrollment on CHIP-AML22\u002FMaster:\n\n   Patients must be enrolled on the CHIP-AML22\u002FMaster prior to enrollment on CHIP-AML\u002FQuizartinib linked-trial, and may have received a diagnostic work-up according to the master protocol. Induction treatment can be started as standard of care.\n2. FLT3-ITD+ and wild-type NPM1:\n\n   Presence of FLT3-ITD+ and NPM1 wild type in bone marrow or peripheral blood provided by the local laboratories, as part of standard of care diagnostics. The results of FLT3-ITD testing must be obtained prior to the first dose of quizartinib (e.g., Induction course 1, Day 10).\n3. Age:\n\n   Patients must be from 1 month to ≤ 18 years old at initial diagnosis\n4. Performance status Karnofsky performance status score of \\>50% for subjects \\>16 years of age, and a Lansky performance status score of \\>50% for subjects ≤16 years of age.\n5. Organ function criteria:\n\n   These criteria must be met based on the results before start of any chemotherapy (e.g., MEC) a. Adequate Renal Function Defined as:\n\n   • Calculated eGFR ≥ 50 mL\u002Fmin\u002F1.73 m2 using the Schwartz formula. b. Adequate Liver Function Defined as:\n   * Total or direct (conjugated) bilirubin \\\u003C 1.5xULN for age (≤ 5xULN if related to leukemic involvement), AND\n   * Aspartate transaminase (AST) and alanine transaminase (ALT) \\\u003C5xULN (\\\u003C10×ULN if related to leukemic involvement)\n6. Life expectancy: \\> 6 weeks\n7. Pregnancy test:\n\n   Serum\u002Furine pregnancy test (for all girls ≥ age of menarche) negative within 2 weeks prior to enrollment on the quizartinib linked-trial.\n8. Taking quizartinib:\n\n   Patients must be able to reliably swallow or administer quizartinib by NG tube.\n9. Informed consent:\n\n   Written informed consent\u002Fassent for the quizartinib linked trial from patients and\u002For from parents or legal guardians for minor patients, according to local law and regulations.\n\n   General exclusion criteria:\n   1. Patients with only extramedullary disease\n   2. Uncontrolled or significant cardiovascular disease, including -Diagnosed or suspected congenital long QT syndrome\n\n      -History of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes); any history of arrhythmia will be discussed with sponsor, the national coordinator and C.I.the prior to subject's entry into the study.\n\n      -QT interval corrected \\>450 ms: QTc interval corrected with Fridericia's formula (QTcF) for subjects ≥ 6 years of age at the time of enrollment.\n\n      -Left ventricular systolic dysfunction (LVSD), defined as ejection fraction (EF) below 55% during the screening for the CHIP-AML22\u002FMaster protocol.\n\n      -History of uncontrolled angina pectoris or myocardial infarction within 6 months.\n\n      -History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have nohistory of fainting or clinically relevant arrhythmias while using the pacemaker).\n\n      -Heart rate \\\u003C50 beats\u002Fminute on ECG during the screening for the CHIP-AML22\u002FMaster protocol (In case,adolescents with a normal sinusoidal rhythm and no evidence of other cardiac dysfunction will be discussed with sponsor, the national coordinator and C.I. the prior to subject's entry into the study.)\n\n      -Uncontrolled hypertension (e.g., systolic blood pressure and \u002For diastolic blood pressure that is, on repeated measurement, at or above the 95th percentile for sex, age, and height).\n      * History of complete left bundle branch block.\n      * History of New York Heart Association Class 3 or 4 heart failure.\n   3. Known history of HIV or active clinically relevant liver disease (e.g., active hepatitis B or active hepatitis C)\n   4. Underlying GI disease that may affect absorption of study drug\n   5. Use of strong or moderate CYP3A inducers will be prohibited throughout the duration of the study. Strong CYP3A4 inhibitors will be allowed with a concomitant dose reduction of quizartinib with the exception during the safety run-in.\n   6. History of hypersensitivity to any of the study medications or their excipients.\n   7. Other serious illnesses or medical conditions, that will likely make it impossible to complete treatment according to protocol (e.g., patients who should not be given any of the study medications based on the SmPC)\n   8. Currently participating in other investigational interventional procedures, if it interferes with any endpoints of the quizartinib trial.\n\n2\\) Additional exclusion criteria during safety run-in:\n\n1. Patients with CNS3 disease\n2. Using strong CYP3A4 inhibitors (If patient can stop using strong CYP3A4 inhibitors, he\u002Fshe will be allowed to enroll. In such case, no washout is required for the strong CYP3A4 inhibitor)","1 Month","18 Years",{"count":55,"type":23},60,[57],"PHASE2","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\u002FQuizartinib) 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.",[30],[61],"FLT3-ITD+ NPM1wt AML","2025-07-31",{"date":64,"type":35},"2025-08-05",{"date":66,"type":35},"2024-02-06",{"date":68,"type":23},"2032-06",{"name":70,"class":42},"Princess Maxima Center for Pediatric Oncology",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":18,"minAge":79,"maxAge":53,"enrollmentInfo":80,"targetDuration":4,"studyType":24,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":71},"100515683","phase-3-chip-aml22master-an-open-label-complex-clinical-trial-in-newly-diagnosed-pediatric-de-novo-aml-patients-100515683","NCT05994690","CHIP-AML22\u002FMaster: An Open Label Complex Clinical Trial in Newly Diagnosed Pediatric de Novo AML Patients","An Open Label Complex Clinical Trial in Newly Diagnosed Pediatric de Novo AML Patients - a Study by the NOPHO-DB-SHIP Consortium, Master Protocol","General inclusion criteria for CHIP-AML22\u002FMaster:\n\nPatients are eligible for the study if they fulfil all four criteria below:\n\n1. Newly diagnosed AML as defined by the diagnostic criteria in section 8.1. Note that different blast thresholds may apply for different genetic abnormalities in case of low blast percentages. The origin of AML must be de novo (not secondary to bone marrow failure or therapy-related).\n2. Age ≥ day and ≤18 years old at initial diagnosis.\n3. Written informed consent\u002Fassent from patients and\u002For from parents or legal guardians for minor patients, according to local law and regulations. Informed consent should ideally be obtained before day 7 of induction course 1, as patients that are eligible for the linked quizartinib trial should be enrolled before the end of induction course 1, and in view of the planned Mylotarg® randomisation. Thus, standard of care diagnostics and induction treatment may be started before informed consent has been obtained.\n4. Able to comply with scheduled follow-up and with management of toxicity.\n\nAdditional inclusion criteria for Ri randomization\n\n1. CD33 positivity of leukemic blasts as measured by flow cytometry at diagnosis (bone marrow aspirate and\u002For peripheral blood).\n2. Informed consent for participation in randomization Ri\n\nAdditional inclusion criteria for Rc randomization\n\n1. Patients included in the CHIP-AML22 protocol and stratified to Standard Risk Group according to the stratification algorithm of the protocol\n2. Informed consent for participation in randomization Rc\n\nGeneral exclusion criteria for CHIP-AML22\u002FMaster\n\nPatients are excluded if any of the criteria below are present:\n\n1. Previous chemotherapy or radiotherapy. This includes patients with therapy-related AML after previous cancer therapy. These patients may be treated according to the master protocol but will not be part of the formal study population, and data of these patients will not be collected.\n2. Patients with a (known) germline predisposition for bone marrow failure, like Fanconi anemia.\n3. Myeloid Leukemia of Down syndrome (ML-DS). Patients with ML-DS are recommended to be treated according to the international ML-DS protocol. Patients with AML and DS older than 5 years who often lack GATA1 mutation and do not have typical myeloid leukemia of DS may be treated according to the master protocol but will not be part of the formal study population, hence data of these patients will not be collected.\n4. Acute promyelocytic leukemia (APL).\n5. Myelodysplastic syndrome (MDS).\n6. Juvenile Myelomonocytic Leukemia (JMML).\n7. Known intolerance to any of the chemotherapeutic drugs in the protocol.\n8. Evidence of cardiac dysfunction (shortening fraction below 28%).\n9. Pregnant or lactating patients, or sexually active female patients of childbearing potential not willing to use an highly effective method of contraception for the duration of study therapy and up to 7 months after the completion of all study therapy.\n10. Sexually active, fertile male patients, not willing to use an effective method of contraception, for the duration of study therapy, and up to 6 months after the completion of all study therapy.\n11. Concomitant administration of any other experimental drug under investigation, or concurrent treatment with any other anti-cancer therapy other than specified in this protocol or in one of the trials linked to this Master protocol, is not allowed.\n12. Patients who in the opinion of the investigator, may not be able to comply with the study requirements of the study.\n13. Patients with known active hepatitis B, hepatitis C, or HIV infection.\n14. Patients for whom informed consent was not obtained.","1 Day",{"count":81,"type":23},905,[83],"PHASE3","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.",[30],{"date":64,"type":35},{"date":88,"type":35},"2023-07-14",{"date":90,"type":23},"2035-12",{"name":70,"class":42},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":53,"enrollmentInfo":99,"targetDuration":4,"studyType":24,"phases":100,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":71},"100534030","individualized-treatment-of-pediatric-rr-aml-based-on-transcriptomic-profile-and-in-vitro-drug-sensitivity-test-100534030","NCT06233526","Individualized Treatment of Pediatric R\u002FR AML Based on Transcriptomic Profile and in Vitro Drug Sensitivity Test","Individualized Treatment of Pediatric Relasped and Refractory Acute Myeloid Leukemia Based on Transcriptomic Profile and in Vitro Drug Sensitivity Test","Inclusion Criteria:\n\n\\- (1) Refractory recurrent acute myeloid leukemia (AML), and after second-line reinduction therapy, such as C+HAG did not reach complete CR.Criteria for complete response, refractory, and recurrence are as follows.\n\n(2) \\\u003C18 years old; (3) The child had good organ function, could tolerate chemotherapy, and had a physical strength score of 0-3 (WHO standard); (4) Understand the research procedures and voluntarily sign written informed consent.\n\nExclusion Criteria:\n\n\\- (1) Acute promyelocytic leukemia, chronic myelogenous leukemia, acute mixed cell leukemia or known central nervous system leukemia; (2) AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Cole's syndrome, or congenital aplastic anemia; (3) secondary to immunodeficiency or positive for human immunodeficiency virus (HIV); (4) Cardiac and renal function were obviously abnormal, and left ventricular ejection fraction was \\\u003C50%.\n\n(5) There is active systemic infection; (6) any medical history or concomitant condition that the investigator believes would impair the subject's safe completion of the study; (7) The investigator considers that the subject is medically unfit to receive the investigational drug or is unfit for any other reason; (8) a known or suspected allergy to the subject drug or to any drug administered in connection with this test;",{"count":55,"type":23},[26],"Acute myeloid leukemia (AML) accounts for about 15% to 20% of childhood leukemia, but the death rate accounts for about 50%. About 20-30% of children with AML did not achieve complete response (CR) after 2 induction treatments, and about 30% of children with CR had relapse within 3 years (including recurrence after hematopoietic stem cell transplantation).Relapsed\u002Frefractory (R\u002FR) AML is a major cause of treatment failure and refractory survival. Reinduction chemotherapy for R\u002FR-AML to obtain CR again, followed by hematopoietic stem cell transplantation, is the current treatment. At present, there is no recognized reinduction protocol, and the reinduction remission rate of R\u002FR-AML varies greatly among different treatment regimens, ranging from 23 to 81%. Current guidelines recommend a new combination chemotherapy regimen consisting of new drugs without cross-resistance. This method selects sensitive chemotherapeutic drugs, and then forms a new combination chemotherapy regimen according to the characteristics of drugs, which is the choice of R\u002FR-AML reinduction therapy.This study intends to conduct a clinical study on the individualized treatment of R\u002FR AML patients through in vitro drug sensitivity test combined with patient transcriptomic characteristics.",[30],[104,105,106,107],"Acute myeloid leukemia","relapsed\u002Frefractory","transcriptomic sequencing","drug sensitivity test","2024-06-30",{"date":110,"type":35},"2024-07-03",{"date":112,"type":35},"2024-01-01",{"date":114,"type":23},"2025-12-31",{"name":116,"class":42},"The Children's Hospital of Zhejiang University School of Medicine"]