[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100260534":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":246,"collaborators":42,"id":249,"slug":250,"hasResults":251,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":42,"eligibilityCriteria":255,"healthyVolunteers":251,"sex":256,"minAge":42,"maxAge":257,"enrollmentInfo":258,"targetDuration":42,"studyType":261,"phases":262,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":281},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cytarabine (\"experimental\") arm","EXPERIMENTAL","On this arm, patients will receive single therapy with cytarabine.",[13],"Drug: Cytarabine",{"label":15,"type":16,"description":17,"interventionNames":18},"Vinblastine\u002Fprednisone (\"standard\") arm","ACTIVE_COMPARATOR","On this arm, patients will receive standard-of-care therapy with vinblastine and prednisone.",[19],"Drug: Vinblastine\u002Fprednisone",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Cytarabine","Cytarabine 100 mg\u002Fm\\^2\u002Fday IV for five consecutive days. This five-day cycle will be repeated every 21 days for a total of four cycles for all patients regardless of response. Each new cycle may not begin until absolute neutrophil count (ANC) is ≥ 750\u002FmcL and platelet count is ≥ 75,000\u002FmcL.",[9],[27],"cytosine arabinoside (ara-C)",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Vinblastine\u002Fprednisone","Vinblastine\u002FPrednisone +\u002F- 6-mercaptopurine based on risk category. Patients with high-risk organ involvement (liver, spleen, hematopoeitic system) will receive 6-mercaptopurine during Continuation Therapy as this is the current standard of care treatment.\n\nVinblastine 6 mg\u002Fm\\^2\u002Fdose IV push weekly for patients ≥ 12 months of age. Vinblastine will be dosed at 3 mg\u002Fm\\^2\u002Fdose for patients under 6 months of age, and dosed at 4.5 mg\u002Fm\\^2\u002Fdose for patients 6 months of age to 11.99 months of age.\n\nPrednisone (or prednisolone) 20 mg\u002Fm2\u002Fdose by mouth twice a day",[15],[33],"Velban\u002FDeltasone",[35],{"name":36,"affiliation":5,"role":37},"Olive Eckstein, MD","STUDY_CHAIR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","832-822-4242",null,"Eckstein@bcm.edu",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Carl E. Allen, MD, PhD","832-826-0860","ceallen@txch.org",[49,72,92,103,122,140,160,178,189,207,226],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Stanford Children's Hospital, Lucile Packard Children's Hospital","RECRUITING","Palo Alto","California","94304","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-122.14302,37.44188,{"lat":61,"lon":60},[64,68],{"name":65,"role":40,"phone":66,"phoneExt":42,"email":67},"Michael Jeng, MD","(650) 723-5535","mjeng@stanford.edu",{"name":69,"role":40,"phone":70,"phoneExt":42,"email":71},"Stephanie Gam","(650) 724-2642","sgam@stanford.edu",{"facility":73,"status":51,"city":74,"state":53,"zip":75,"country":55,"countryCode":56,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Rady Children's Hospital - San Diego","San Diego","92123",{"type":58,"coordinates":77},[78,79],-117.16472,32.71571,{"lat":79,"lon":78},[82,85,90],{"name":83,"role":40,"phone":42,"phoneExt":42,"email":84},"Jennifer Yu, MD","jyu@rchsd.org",{"name":86,"role":40,"phone":87,"phoneExt":88,"email":89},"Sherri Brandsen","858-966-1700","226235","sbrandsen@rchsd.org",{"name":83,"role":91,"phone":42,"phoneExt":42,"email":42},"PRINCIPAL_INVESTIGATOR",{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":55,"countryCode":56,"cosmosGeoPoint":98,"geoPoint":102,"contacts":42},"University of Minnesota\u002FMasonic Cancer Center","WITHDRAWN","Minneapolis","Minnesota","55455",{"type":58,"coordinates":99},[100,101],-93.26384,44.97997,{"lat":101,"lon":100},{"facility":104,"status":51,"city":105,"state":106,"zip":107,"country":55,"countryCode":56,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Nationwide Children's Hospital","Columbus","Ohio","43205",{"type":58,"coordinates":109},[110,111],-82.99879,39.96118,{"lat":111,"lon":110},[114,118],{"name":115,"role":40,"phone":116,"phoneExt":42,"email":117},"Amanda Jacobson-Kelly, MD","(614) 722-3510","Amanda.Jacobson-Kelly@nationwidechildrens.org",{"name":119,"role":40,"phone":120,"phoneExt":42,"email":121},"Myra Christian-Rancy","(614) 722-3690","Myra.Christian-Rancy@nationwidechildrens.org",{"facility":123,"status":51,"city":124,"state":125,"zip":126,"country":55,"countryCode":56,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Lehigh Valley Health Network- Cedar Crest","Allentown","Pennsylvania","18103",{"type":58,"coordinates":128},[129,130],-75.49018,40.60843,{"lat":130,"lon":129},[133,136],{"name":134,"role":40,"phone":42,"phoneExt":42,"email":135},"Jacob Troutman, DO","Jacob.Troutman@lvhn.org",{"name":137,"role":40,"phone":138,"phoneExt":42,"email":139},"Annmarie Steber","(610) 402-3078","annmarie.steber@lvhn.org",{"facility":141,"status":51,"city":142,"state":143,"zip":144,"country":55,"countryCode":56,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Dell Children's Medical Center","Austin","Texas","78723",{"type":58,"coordinates":146},[147,148],-97.74306,30.26715,{"lat":148,"lon":147},[151,155,159],{"name":152,"role":40,"phone":153,"phoneExt":42,"email":154},"Virgina Harrod, MD, PhD","512-628-1900","vlharrod@ascension.org",{"name":156,"role":40,"phone":157,"phoneExt":42,"email":158},"Rhea Robinson","512-628-1902","rmrobinson@ascension.org",{"name":152,"role":91,"phone":42,"phoneExt":42,"email":42},{"facility":161,"status":51,"city":162,"state":143,"zip":163,"country":55,"countryCode":56,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Cook Children's Health Care System","Fort Worth","76104",{"type":58,"coordinates":165},[166,167],-97.32085,32.72541,{"lat":167,"lon":166},[170,174],{"name":171,"role":40,"phone":172,"phoneExt":42,"email":173},"Anish Ray, MD","(682) 885-4007","Anish.Ray@cookchildrens.org",{"name":175,"role":40,"phone":176,"phoneExt":42,"email":177},"Heather Downs","(685) 885-3379","Heather.Downs@cookchildrens.org",{"facility":179,"status":51,"city":180,"state":143,"zip":181,"country":55,"countryCode":56,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Texas Children's Hospital","Houston","77030",{"type":58,"coordinates":183},[184,185],-95.36327,29.76328,{"lat":185,"lon":184},[188],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},{"facility":190,"status":51,"city":191,"state":143,"zip":192,"country":55,"countryCode":56,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Vannie Cook Children's Clinic","McAllen","78503",{"type":58,"coordinates":194},[195,196],-98.23001,26.20341,{"lat":196,"lon":195},[199,203],{"name":200,"role":40,"phone":201,"phoneExt":42,"email":202},"Juan C Bernini, MD","(956) 661-9840","jcbernin@txch.org",{"name":204,"role":40,"phone":205,"phoneExt":42,"email":206},"Jill Hartley","(832) 828-1727","jrhartl1@txch.org",{"facility":208,"status":51,"city":209,"state":143,"zip":210,"country":55,"countryCode":56,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Children's Hospital of San Antonio","San Antonio","78207",{"type":58,"coordinates":212},[213,214],-98.49363,29.42412,{"lat":214,"lon":213},[217,221,225],{"name":218,"role":40,"phone":219,"phoneExt":42,"email":220},"Timothy Griffin, MD","210-704-2187","Timothy.Griffin@bcm.edu",{"name":222,"role":40,"phone":223,"phoneExt":42,"email":224},"Bridget Medina","210-704-2894","bridget.medina@christushealth.org",{"name":218,"role":91,"phone":42,"phoneExt":42,"email":42},{"facility":227,"status":51,"city":228,"state":229,"zip":230,"country":55,"countryCode":56,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"Children's Hospital of The King's Daughters","Norfolk","Virginia","23507",{"type":58,"coordinates":232},[233,234],-76.28522,36.84681,{"lat":234,"lon":233},[237,241,245],{"name":238,"role":40,"phone":239,"phoneExt":42,"email":240},"William Owen, MD","757-668-7243","William.Owen@chkd.org",{"name":242,"role":40,"phone":243,"phoneExt":42,"email":244},"Sabrina Wiggington","757-668-7909","Sabrina.Wigginton@chkd.org",{"name":238,"role":91,"phone":42,"phoneExt":42,"email":42},{"type":91,"investigatorFullName":247,"investigatorTitle":248,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Olive Eckstein","Assistant Professor","100260534","phase-3-vinblastineprednisone-versus-single-therapy-with-cytarabine-for-langerhans-cell-histiocytosis-lch-100260534",false,"NCT02670707","Vinblastine\u002FPrednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)","Randomization of Cytarabine Monotherapy Versus Standard-of-Care Vinblastine\u002FPrednisone for Frontline Treatment of Langerhans Cell Histiocytosis (TXCH LCH0115)","Inclusion Criteria:\n\n1. Patient must have biopsy-confirmed diagnosis of Langerhans cell histiocytosis.\n2. Patient must be between 0-21 years of age.\n3. Patient must have a Karnofsky performance score ≥ 50% or Lansky performance score ≥ 50%.\n\nExclusion Criteria:\n\n1. Patient may not have received any prior systemic cytotoxic or other chemotherapies for LCH or any other malignant disorder prior to the initiation of protocol therapy on TXCH LCH0115 with the exception of:\n\n   Steroid pretreatment: Systemic glucocorticosteroids (prednisone, methylprednisone, dexamethasone, etc.) for less than or equal to 120 hours (5 days) in the 7 days prior to initiating protocol therapy or for less than or equal to 336 hours (14 days) in the 28 days before the initiation of protocol therapy does not affect eligibility. The dose of steroid previously given does not affect eligibility. Patients who have only received surgical or radiation therapy, intralesional injection of steroids, inhalational steroids, systemic mineralocorticoids (hydrocortisone), or topical steroids may also be enrolled.\n2. Patient may not have disease limited to a single skin or bone site, with the following exceptions:\n\n   * Central Nervous System (CNS) risk lesions\u002Fspecial site disease: patients with single bone sites that are CNS-risk (sphenoid, mastoid, orbital, zygomatic, ethmoid, maxillary, or temporal bones, the cranial fossa, pituitary gland or neurodegenerative disease) or are \"special sites\" (odontoid peg, vertebral lesion with intraspinal soft tissue extension) require systemic therapy as standard of care and thus are eligible for the study.\n   * Functionally critical lesions: A single lesion not described above which may cause \"functionally critical anatomic abnormality\" wherein attempts at local therapy (such as surgical curettage or radiation) would cause unacceptable morbidity. These patients may be enrolled with written approval of the Coordinating Center PI or Vice-Chair and documentation of the rationale justifying systemic therapy.\n   * Asynchronous multisite LCH presentation: A patient may also have any single site of disease involvement at the time of enrollment if they previously had at least one other site of LCH disease in the past (which may have been treated with local therapy\u002Fsurgery as described), as long as no systemic therapy was previously given per protocol guidelines.\n3. Patient may not have severe renal disease (creatinine greater than 3 times normal for age OR creatinine clearance \\\u003C 50 ml\u002Fm2\u002F1.73m\\^2).\n4. Patient may not have severe hepatic disease (direct bilirubin greater than 3 mg\u002Fdl OR aspartate aminotransferase (AST) greater than 500 IU\u002FL), unless hepatic injury is due to LCH.\n5. Female patients may not be pregnant or breastfeeding.\n6. Patients of reproductive potential not willing to use an adequate method of birth control for the duration of the study.\n7. Patients who are HIV positive may not be enrolled.\n\nNOTE: Patients excluded for laboratory abnormalities or performance score only may be enrolled on the study with written approval from the Coordinating Center PI or Vice-Chair.","ALL","21 Years",{"count":259,"type":260},124,"ESTIMATED","INTERVENTIONAL",[263],"PHASE3","Langerhans Cell Histiocytosis (LCH) is a type of cancer that can damage tissue or cause lesions to form in one or more places in the body. Langerhans cell histiocytosis (LCH) is a cancer that begins in LCH cells (a type of dendritic cell which fights infection). Sometimes there are mutations (changes) in LCH cells as they form. These include mutations of the BRAF gene. These changes may make the LCH cells grow and multiply quickly. This causes LCH cells to build up in certain parts of the body, where they can damage tissue or form lesions.\n\nFor most patients with LCH, standard-of-care vinblastine\u002Fprednisone are used as front-line therapy while cytarabine therapy has been used as therapy for patients who develop recurrence. No alternate treatment strategy has been developed for frontline therapy in LCH.\n\nThe purpose of this research study is to compare previously used vinblastine\u002Fprednisone to single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study called a positron emission tomography (PET) scan to more accurately assess areas of LCH involvement not otherwise seen in other imaging studies as well as response to therapy. We also want to identify if genetic and other biomarkers (special proteins in patient's blood and in patient's cancer) relate to the response of patients LCH to study treatment.",[266],"Langerhans Cell Histiocytosis",[268,269,270,271],"vinblastine","prednisone","cytarabine","Langerhans Cell Histiocytosis (LCH)","2025-09-05",{"date":274,"type":275},"2025-09-11","ACTUAL",{"date":277,"type":275},"2016-03-07",{"date":279,"type":260},"2029-01",{"name":5,"class":6},11]