[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659715":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":38,"studyPopulation":31,"armGroups":39,"interventions":51,"overallOfficials":31,"centralContacts":57,"locations":63,"responsibleParty":87,"collaborators":31,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":31,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":31,"maxAge":99,"enrollmentInfo":100,"targetDuration":31,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":66,"whyStopped":31,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":31},[9,13],{"measure":10,"description":11,"timeFrame":12},"Efficacy of low dose induction for pediatric AML","assessment of each induction response by performing bone marrow aspirate and analysis of each participant response. BM response may be: CR (complete remission), PR (partial remission), NR(no response) or induction deaths","6 years",{"measure":14,"description":15,"timeFrame":12},"number of participants with low dose induction-related Toxicity assessed by CTCAE v5","the common terminology criteria for adverse events (CTCAE v5) using a range of grades (1-5):\n\n1. mild\n2. moderate\n3. severe\n4. life threatening\n5. death",[17,21,24,26,28],{"measure":18,"description":19,"timeFrame":20},"Event free survival of AML patients with low dose induction","time from enrollment to occurrence of any event (death, induction failure, refractory relapse or 2nd malignancy) or to last follow up of living patients using Kaplan Meier and hazard cox regression survival analysis","10 years",{"measure":22,"description":23,"timeFrame":20},"Overall survival of pediatric patients with AML using low dose induction","time from enrollment to occurrence of death of any cause or to last follow up of living patients using Kaplan Meier and hazard cox regression survival analysis",{"measure":25,"description":19,"timeFrame":20},"Event Free Survival of unfavourable and favourable sub groups of AML patients with low dose induction",{"measure":27,"description":15,"timeFrame":20},"number of participants with Long term low dose induction related- toxicities assessed by CTCAE v5",{"measure":29,"description":30,"timeFrame":12},"Duration of neutrophil recovery after low dose induction","calculating days of neutropenia after dose till recovery",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":31},"NONE","Acute myeloid leukemia (AML) accounts for 15% to 20% of all childhood leukemias. In most children, AML presents as a de novo entity, but in a minority, it is a secondary malignancy. Acute myeloid leukemia is a heterogeneous disease and its diagnosis involves a combination of diagnostic analyses including morphology, immunophenotyping, cytochemistry, and leukemic blasts derived from peripheral blood or bone marrow demonstrating cytogentic and molecular characteristics. The treatment of AML comprises induction of remission followed by intensive consolidation therapy with the use of chemotherapy alone or in combination with allogeneic hematopoietic stem cell transplantation (HSCT). The standard chemotherapy courses for remission induction and consolidation are typically accompanied by an extended period of myelosuppression during which there is significant morbidity and mortality. Treatment-related morbidity and treatment-related mortality (TRM) represents a significant challenge in pediatric AML worldwide. In low- and middle- income countries (LMICs), mortality associated with initial disease and treatment can be up to 50 %. It is now well understood and accepted that if the relapse rate with a given therapy is excessive then the treatment may need intensification; however, if toxic death rates are too high, de-intensification may save more lives, depending on the enhancement of supportive care. During tumor formation, new mutations are constantly occurring giving rise to drug resistant mutation at a very low frequency. With the pre- existence of small drug-resistant sub clones giving the current chemotherapy at the maximum tolerated dose that eliminates a dominant drug sensitive clone might allow the competitive release of resistant sub clones to undergo accelerated growth in a resource-rich environment, resulting in more rapid disease progression or relapse. Reducing chemotherapy drug dosage may be a logical way to maintain a stable population of sensitive sub clone, thereby restricting the growth of resistant cell. Intensifying the induction courses can decrease relapse rates but not improve OS. The initial concerns for offering a low dose intensity regimen for children with AML in most studies was based on the high risk of toxicity related deaths or treatment abandonment specially for children in limited resources countries. According to SIOP\u002FPODC, patients with AML treated with low dose chemotherapy (LDC\u002FG-CSF) receive only a two -drug regimen with 10 \\& 2 times lower doses of cytrabine \\& anthracyclines respectively than those given standard AML remission induction regimens. Although the mechanism \\& clinical efficacy of LDC\u002FG-CSF are still unknown, it is possible that granulocyte colony stimulating factor (G-CSF) makes leukemia cells more vulnerable to chemotherapy through sensitization or priming.G-CSF can also reduce the overall viability of AML cells when cocultured with BM stroma but not alone. G- CSF mobilizes T-regulatory cells and has other immunomodulatory effects.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"low dose induction\u002FGCSF","EXPERIMENTAL","low dose Ara C, mitothantrone concurrently with GCSF",[45],"Combination Product: Low dose Ara C\u002F anthracycline combined with GCSF",{"label":47,"type":48,"description":49,"interventionNames":50},"Standard induction","ACTIVE_COMPARATOR","the established, standard induction regimen, ADE",[45],[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":31},"COMBINATION_PRODUCT","Low dose Ara C\u002F anthracycline combined with GCSF","low dose mitothantrone and Ara C concurrently with G-CSF during induction treatment of pediatric acute myeloid leukemia to be compared with the standard induction",[47,41],[58],{"name":59,"role":60,"phone":61,"phoneExt":31,"email":62},"Azza Shibl, MD","CONTACT","00201021880322","azzashibl@aun.edu.eg",[64,78],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":31},"South Egypt Cancer Institute, Assiut Univeristy","RECRUITING","Asyut","Asyut Governorate","71515","Egypt","EG",{"type":73,"coordinates":74},"Point",[75,76],31.18368,27.18096,{"lat":76,"lon":75},{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":79,"geoPoint":81,"contacts":82},{"type":73,"coordinates":80},[75,76],{"lat":76,"lon":75},[83],{"name":84,"role":60,"phone":85,"phoneExt":31,"email":86},"Omima Shaker, Master","00201019739885","dromimaali@aun.edu.eg",{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Azza Shibl Sayed","assisstant professor of peditric oncology","100659715","low-dose-induction-for-pediatric-acute-myeloid-leukemia-patients-100659715",false,"NCT07867600","Low Dose Induction for Pediatric Acute Myeloid Leukemia Patients","Outcome of Pediatric Patients With Acute Myeloid Leukemia Treated According to SIOP Guidelines in Developing Countries","Inclusion Criteria:\n\n* Denovo pediatric AML patients.\n* equal or \\\u003C18 years old\n\nExclusion Criteria:\n\n* Children with promyelocytic leukemia\n* Down syndrome with AML with age less than 4 years.\n* AML secondary to myelodysplastic syndrome or prior chemotherapy.\n* death before treatment initiation","ALL","18 Years",{"count":101,"type":102},33,"ESTIMATED","INTERVENTIONAL",[105],"NA","the standard induction treatment for pediatric acute myeloid leukemia has high early morbidity and mortality that jeopardize the outcome especially in developing countries. SIOP recommended lower dose induction synergistic G- CSF to minimize these unwanted toxicities. the study aimed at minimizing the toxicities during induction without jeopardizing the survival.",[108],"Pediatric Acute Myeloid Leukemia Induction",[110,111,112,113,114],"MAG\u002FGCSF","pediatric AML","SIOP-PODC","Survival","Toxicity","2026-10-07",{"date":117,"type":118},"2026-10-09","ACTUAL",{"date":120,"type":118},"2022-07-28",{"date":122,"type":102},"2030-07",{"name":89,"class":6},2]