[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445598":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":247,"collaborators":251,"id":253,"slug":254,"hasResults":255,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":255,"sex":261,"minAge":262,"maxAge":263,"enrollmentInfo":264,"targetDuration":18,"studyType":267,"phases":268,"briefSummary":270,"conditions":271,"keywords":274,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":289},{"fullName":5,"class":6},"Therapeutic Advances in Childhood Leukemia Consortium","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IDEAL2 intervention","EXPERIMENTAL","Focused and short-term intervention of diet and exercise during induction. Calorie goal is \\>=15% daily deficit as determined by each subject's estimated energy requirement. Fat intake will make up \\\u003C25% of daily calories. Carbohydrate will make up \\\u003C55% of daily calories consisting of \"low\" glycemic load foods (\\\u003C100\u002F2,000 kcal adjusted for daily calories). Protein will make up \\>=20% of daily calories. Subjects will also perform moderate exercise 5 days per week for 30 minutes\u002Fsession (total = 150 minutes per week). Subjects will have a step goal to decrease sedentary behavior, with a starting goal of \\>=1000 steps\u002Fday and increasing by at least 1000 steps\u002Fday each week.",[13],"Behavioral: IDEAL2 Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control - Standard of Care","NO_INTERVENTION","One-time education of diet and exercise, which is the standard of care for ALL patients during induction.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","IDEAL2 Intervention","Intervention of diet and exercise to improve outcomes for ALL patients",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Ellynore Florendo","CONTACT","323-361-3022","eflorendo@chla.usc.edu",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Suganya Rajendran","323-361-8835","srajendran@chla.usc.edu",[36,54,66,78,91,105,118,131,144,157,170,183,196,209,222,234],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Children's Hospital Los Angeles","RECRUITING","Los Angeles","California","90027","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-118.24368,34.05223,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":18,"phoneExt":18,"email":18},"Etan Orgel, MD","PRINCIPAL_INVESTIGATOR",{"facility":55,"status":38,"city":56,"state":40,"zip":57,"country":42,"countryCode":43,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Children's Hospital Orange County","Orange","92868",{"type":45,"coordinates":59},[60,61],-117.85311,33.78779,{"lat":61,"lon":60},[64],{"name":65,"role":53,"phone":18,"phoneExt":18,"email":18},"Van Huynh, MD",{"facility":67,"status":38,"city":68,"state":40,"zip":69,"country":42,"countryCode":43,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"UCSF School of Medicine","San Francisco","94158",{"type":45,"coordinates":71},[72,73],-122.41942,37.77493,{"lat":73,"lon":72},[76],{"name":77,"role":53,"phone":18,"phoneExt":18,"email":18},"Michelle Hermiston, MD",{"facility":79,"status":38,"city":80,"state":81,"zip":82,"country":42,"countryCode":43,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Colorado Children's Hospital","Denver","Colorado","80045",{"type":45,"coordinates":84},[85,86],-104.9847,39.73915,{"lat":86,"lon":85},[89],{"name":90,"role":28,"phone":18,"phoneExt":18,"email":18},"Lisa Hartman, M.D.",{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":42,"countryCode":43,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Children's Healthcare of Atlanta at Egleston","NOT_YET_RECRUITING","Atlanta","Georgia","30322",{"type":45,"coordinates":98},[99,100],-84.38798,33.749,{"lat":100,"lon":99},[103],{"name":104,"role":53,"phone":18,"phoneExt":18,"email":18},"Melinda Pauly, MD",{"facility":106,"status":38,"city":107,"state":108,"zip":109,"country":42,"countryCode":43,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Ann & Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"type":45,"coordinates":111},[112,113],-87.65005,41.85003,{"lat":113,"lon":112},[116],{"name":117,"role":53,"phone":18,"phoneExt":18,"email":18},"Jenna Rossoff, MD",{"facility":119,"status":38,"city":120,"state":121,"zip":122,"country":42,"countryCode":43,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Children's Mercy Hospital","Kansas City","Kansas","64108",{"type":45,"coordinates":124},[125,126],-94.62746,39.11417,{"lat":126,"lon":125},[129],{"name":130,"role":28,"phone":18,"phoneExt":18,"email":18},"Keith August, MD",{"facility":132,"status":38,"city":133,"state":134,"zip":135,"country":42,"countryCode":43,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"C.S. Mott University of Michigan","Ann Arbor","Michigan","48109",{"type":45,"coordinates":137},[138,139],-83.74088,42.27756,{"lat":139,"lon":138},[142],{"name":143,"role":28,"phone":18,"phoneExt":18,"email":18},"Jennifer Agrusa, M.D.",{"facility":145,"status":38,"city":146,"state":147,"zip":148,"country":42,"countryCode":43,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Children's Hospitals and Clinics of Minnesota","Minneapolis","Minnesota","55404",{"type":45,"coordinates":150},[151,152],-93.26384,44.97997,{"lat":152,"lon":151},[155],{"name":156,"role":53,"phone":18,"phoneExt":18,"email":18},"Nathan Gossai, MD",{"facility":158,"status":38,"city":159,"state":160,"zip":161,"country":42,"countryCode":43,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Levine Children's Hospital","Charlotte","North Carolina","28203",{"type":45,"coordinates":163},[164,165],-80.84313,35.22709,{"lat":165,"lon":164},[168],{"name":169,"role":53,"phone":18,"phoneExt":18,"email":18},"Joel Kaplan, DO",{"facility":171,"status":38,"city":172,"state":173,"zip":174,"country":42,"countryCode":43,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":45,"coordinates":176},[177,178],-84.51439,39.12711,{"lat":178,"lon":177},[181],{"name":182,"role":28,"phone":18,"phoneExt":18,"email":18},"Robin Norris, MD",{"facility":184,"status":38,"city":185,"state":186,"zip":187,"country":42,"countryCode":43,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Oregon Health & Science University","Portland","Oregon","97239",{"type":45,"coordinates":189},[190,191],-122.67621,45.52345,{"lat":191,"lon":190},[194],{"name":195,"role":53,"phone":18,"phoneExt":18,"email":18},"Bill Chang, MD",{"facility":197,"status":38,"city":198,"state":199,"zip":200,"country":42,"countryCode":43,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":45,"coordinates":202},[203,204],-75.16362,39.95238,{"lat":204,"lon":203},[207],{"name":208,"role":53,"phone":18,"phoneExt":18,"email":18},"Susan Rheingold, MD",{"facility":210,"status":38,"city":211,"state":212,"zip":213,"country":42,"countryCode":43,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"University of Texas, Southwestern","Dallas","Texas","75235",{"type":45,"coordinates":215},[216,217],-96.80667,32.78306,{"lat":217,"lon":216},[220],{"name":221,"role":28,"phone":18,"phoneExt":18,"email":18},"Tamra Slone, MD",{"facility":223,"status":38,"city":224,"state":212,"zip":225,"country":42,"countryCode":43,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Baylor Texas Children's Hospital","Houston","77030",{"type":45,"coordinates":227},[228,229],-95.36327,29.76328,{"lat":229,"lon":228},[232],{"name":233,"role":28,"phone":18,"phoneExt":18,"email":18},"Karen Rabin, M.D.",{"facility":235,"status":38,"city":236,"state":237,"zip":238,"country":42,"countryCode":43,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"Primary Children's Hospital","Salt Lake City","Utah","84113",{"type":45,"coordinates":240},[241,242],-111.89105,40.76078,{"lat":242,"lon":241},[245],{"name":246,"role":28,"phone":18,"phoneExt":18,"email":18},"Mallorie Heneghan, M.D.",{"type":248,"investigatorFullName":249,"investigatorTitle":250,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Etan Orgel","Principal Investigator",[252],{"name":5,"class":6},"100445598","phase-2-caloric-restriction-and-activity-to-reduce-chemoresistance-in-b-all-100445598",false,"NCT05082519","Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL","A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-cell Acute Lymphoblastic Leukemia","IDEAL2","Inclusion Criteria:\n\n* Patients must be ≥ 7.0 and \\\u003C26.0 years of age.\n* Patients must have a diagnosis of de novo B-ALL\n* Patients must have a M3 marrow (\\>25% blasts by morphology) or at least 1,000\u002FµL circulating leukemia cells in PB confirmed by Flow Cytometry (or other convincing evidence of a B-ALL diagnosis not meeting above criteria following central review by the Study Hematopathologist and Study Chair or Vice-Chair).\n* The treatment regimen must be the first treatment attempt for B-ALL-\n* Must be a multi-agent induction regimen inclusive of vincristine, glucocorticoid, pegaspargase\u002Fcalaspargase, and daunorubicin or doxorubicin and with a planned duration \\\u003C35 days.\n* Organ function must meet that required for initiation of chemotherapy\n* Patients at diagnosis must meet Karnofsky \\> 50% for patients \\> 16 years of age and Lansky \\> 50% for patients ≤ 16 years of age (or be expected to recover prior to Day 8) .\n* If the patient is a female of childbearing potential, a negative urine or serum pregnancy test is required within two weeks prior to enrollment.\n\nExclusion Criteria:\n\n* Patient will be excluded if they are underweight at time of enrollment (BMI% \\\u003C5th percentile for age for patients age 10-19 years, BMI \\\u003C18.5 in patients 20-29 years).\n* Patients with Down syndrome or a DNA fragility syndrome (such as Fanconi anemia, Bloom syndrome) will be excluded.\n* Patient receiving a SJCRH-style \"Total Therapy\" regimen will be excluded.\n* Patients receiving anti-CD20 monoclonal antibody therapy during induction therapy.\n* Patients will be excluded if they received treatment for a previous malignancy.\n* Patient will be excluded if they are pregnant.\n* Patient will be excluded if they have a pre-diagnosis requirement for enteral or parenteral supplementation .\n* Patient will be excluded due to inability to perform the intervention (e.g., specific nutritional needs, severe developmental delay, paraplegia)\n* Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results","ALL","7 Years","25 Years",{"count":265,"type":266},240,"ESTIMATED","INTERVENTIONAL",[269],"PHASE2","This study is for older children, adolescents, and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Higher amounts of body fat is associated with resistance to chemotherapy in patients with B-ALL. Chemotherapy during the first month causes large gains in body fat in most people, even those who start chemotherapy at a healthy weight.\n\nThis study is being done to find out if caloric restriction achieved by a personalized nutritional menu and exercise plan during routine chemotherapy can make the patient's ALL more sensitive to chemotherapy and also reduce the amount of body fat gained during treatment. The goals of this study are to help make chemotherapy more effective in treating the patient's leukemia as demonstrated by fewer patients with leukemia minimal residual disease (MRD) while also trying to reduce the amount of body fat that chemotherapy causes the patient to gain in the first month.",[272,273],"B-cell Acute Lymphoblastic Leukemia","Obesity",[275,276,277,278,279],"obesity","leukemia","B-cell leukemia","Pediatric obesity","Pediatric ALL","2026-08-17",{"date":282,"type":283},"2026-08-19","ACTUAL",{"date":285,"type":283},"2022-03-12",{"date":287,"type":266},"2032-08-15",{"name":249,"class":6},16]