[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546083":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":123,"centralContacts":127,"locations":133,"responsibleParty":182,"collaborators":184,"id":188,"slug":189,"hasResults":190,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":131,"eligibilityCriteria":194,"healthyVolunteers":190,"sex":195,"minAge":196,"maxAge":197,"enrollmentInfo":198,"targetDuration":131,"studyType":201,"phases":202,"briefSummary":204,"conditions":205,"keywords":209,"overallStatus":136,"whyStopped":131,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",[8,25,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with T-ALL (except ETP or near-ETP)","EXPERIMENTAL","All eligible patients receive intervention according to the Detailed Description section with the following:\n\nInduction: Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Dasatinib, IT MHA\n\nEarly Post Induction: Cyclophosphamide, Cytarabine, Mercaptopurine, Nelarabine, IT MHA, Methotrexate, Dasatinib, Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol\n\nMaintenance: Mercaptopurine, Methotrexate, Nelarabine, Cyclophosphamide, Cytarabine, Dexamethasone, Vincristine, Dasatinib, IT MHA, Thioguanine",[13,14,15,16,17,18,19,20,21,22,23,24],"Drug: Dexamethasone","Drug: Vincristine","Drug: Daunorubicin","Drug: Calaspargase pegol","Drug: Dasatinib","Drug: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)","Drug: Cyclophosphamide","Drug: Cytarabine","Drug: Mercaptopurine","Drug: Nelarabine","Drug: Methotrexate","Drug: Thioguanine",{"label":26,"type":10,"description":27,"interventionNames":28},"Patients with ETP or near-ETP ALL or MPAL","All eligible patients receive intervention according to the Detailed Description section with the following:\n\nInduction: Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Venetoclax, IT MHA\n\nEarly Post Induction: Cyclophosphamide, Cytarabine, Mercaptopurine, Nelarabine, IT MHA, Methotrexate, Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Venetoclax\n\nMaintenance: Mercaptopurine, Methotrexate, Nelarabine, Cyclophosphamide, Cytarabine, Dexamethasone, Vincristine, IT MHA, Thioguanine",[13,14,15,16,29,18,19,20,21,22,23,24],"Drug: Venetoclax",{"label":31,"type":10,"description":32,"interventionNames":33},"Patients with T-LLy","All eligible patients receive intervention according to the Detailed Description section with the following:\n\nInduction: Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Bortezomib, IT MHA\n\nEarly Post Induction: Cyclophosphamide, Cytarabine, Mercaptopurine, IT MHA, Methotrexate, Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Bortezomib\n\nMaintenance: Mercaptopurine, Methotrexate, Cyclophosphamide, Cytarabine, Dexamethasone, Vincristine, IT MHA, Thioguanine",[13,14,15,16,34,18,19,20,21,23,24],"Drug: Bortezomib",[36,44,51,56,61,67,73,79,85,90,97,103,110,116],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Dexamethasone","Given orally (PO) or intravenously (IV).",[26,9,31],[42,43],"Decadron","Hexadrol®",{"type":37,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Vincristine","Given IV.",[26,9,31],[49,50],"Vincristine Sulfate","Oncovin",{"type":37,"name":52,"description":46,"armGroupLabels":53,"otherNames":54},"Daunorubicin",[26,9,31],[55],"Daunomycin",{"type":37,"name":57,"description":46,"armGroupLabels":58,"otherNames":59},"Calaspargase pegol",[26,9,31],[60],"ASPARLAS",{"type":37,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Dasatinib","Given PO",[9],[66],"Sprycel®",{"type":37,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"Venetoclax","Given PO (ETP, near-ETP, and MPAL only).",[26],[72],"Venclexta®",{"type":37,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"Bortezomib","Given IV (T-LLy only).",[31],[78],"Velcade®",{"type":37,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)","Given Intrathecal (IT), Age adjusted.",[26,9,31],[84],"IT MHA",{"type":37,"name":86,"description":46,"armGroupLabels":87,"otherNames":88},"Cyclophosphamide",[26,9,31],[89],"Cytoxan®",{"type":37,"name":91,"description":92,"armGroupLabels":93,"otherNames":94},"Cytarabine","Given IV or IT.",[26,9,31],[95,96],"Ara-C","Cytosine arabinoside",{"type":37,"name":98,"description":99,"armGroupLabels":100,"otherNames":101},"Mercaptopurine","Given PO.",[26,9,31],[102],"6-MP",{"type":37,"name":104,"description":105,"armGroupLabels":106,"otherNames":107},"Nelarabine","Given IV",[26,9],[108,109],"Arranon","Atriance",{"type":37,"name":111,"description":112,"armGroupLabels":113,"otherNames":114},"Methotrexate","Given IT, IV, PO or intramuscular (IM).",[26,9,31],[115],"Trexall®",{"type":37,"name":117,"description":118,"armGroupLabels":119,"otherNames":120},"Thioguanine","Given PO (participants intolerant to mercaptopurine).",[26,9,31],[121,122],"6-thioguanine","Tabloid®",[124],{"name":125,"affiliation":5,"role":126},"Seth E. Karol, MD, MSCI","PRINCIPAL_INVESTIGATOR",[128],{"name":125,"role":129,"phone":130,"phoneExt":131,"email":132},"CONTACT","888-226-4343",null,"referralinfo@stjude.org",[134,154,170],{"facility":135,"status":136,"city":137,"state":138,"zip":139,"country":140,"countryCode":141,"cosmosGeoPoint":142,"geoPoint":147,"contacts":148},"Rady Children's Hospital","RECRUITING","San Diego","California","92123","United States","US",{"type":143,"coordinates":144},"Point",[145,146],-117.16472,32.71571,{"lat":146,"lon":145},[149,153],{"name":150,"role":129,"phone":151,"phoneExt":131,"email":152},"Victor Wong, MD","858-966-5811","vwong@rchsd.org",{"name":150,"role":126,"phone":131,"phoneExt":131,"email":131},{"facility":155,"status":136,"city":156,"state":157,"zip":158,"country":140,"countryCode":141,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Saint Francis Children's Hospital","Tulsa","Oklahoma","74136",{"type":143,"coordinates":160},[161,162],-95.99277,36.15398,{"lat":162,"lon":161},[165,169],{"name":166,"role":129,"phone":167,"phoneExt":131,"email":168},"Ashraf Mohamed, MD","918-502-6720","ammohamed@saintfrancis.com",{"name":166,"role":126,"phone":131,"phoneExt":131,"email":131},{"facility":5,"status":136,"city":171,"state":172,"zip":173,"country":140,"countryCode":141,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Memphis","Tennessee","38105",{"type":143,"coordinates":175},[176,177],-90.04898,35.14953,{"lat":177,"lon":176},[180,181],{"name":125,"role":129,"phone":130,"phoneExt":131,"email":132},{"name":125,"role":126,"phone":131,"phoneExt":131,"email":131},{"type":183,"investigatorFullName":131,"investigatorTitle":131,"investigatorAffiliation":131,"oldNameTitle":131,"oldOrganization":131},"SPONSOR",[185],{"name":186,"class":187},"AbbVie","INDUSTRY","100546083","phase-2-adding-dasatinib-or-venetoclax-to-improve-responses-in-children-with-newly-diagnosed-t-cell-acute-lymphoblastic-leukemia-all-or-lymphoma-t-lly-or-mixed-phenotype-acute-leukemia-mpal-100546083",false,"NCT06390319","Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)","SJALL23T: Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)","Inclusion Criteria:\n\n* Enrollment on INITIALL.\n* Age 1-18.99 years at the time of enrollment on INITIALL.\n* T-Acute lymphoblastic leukemia or lymphoblastic lymphoma or mixed phenotype acute leukemia\u002F lymphoma\n* No prior chemotherapy excluding therapy given on or allowed by INITIALL.\n* Patient has completed no more than 3 days of chemotherapy on INITIALL.\n* Direct bilirubin ≤ 1.5x the upper limit of normal for age\n* Alanine aminotransferase (ALT) ≤ 5x the upper limit of normal for age\n* Calculated glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73m\\^2 using the Bedside Schwartz equation OR creatinine below or equal to the maximum defined below:\n\n  * Age: 1 to \\\u003C 2 years - Maximum serum creatinine (mg\u002FdL): 0.6 (Male), 0.6 (Female)\n  * Age: 2 to \\\u003C 6 years - Maximum serum creatinine (mg\u002FdL): 0.8 (Male), 0.8 (Female)\n  * Age: 6 to \\\u003C 10 years - Maximum serum creatinine (mg\u002FdL): 1 (Male), 1 (Female)\n  * Age: 10 to \\\u003C 13 years - Maximum serum creatinine (mg\u002FdL): 1.2 (Male), 1.2 (Female)\n  * Age: 13 to \\\u003C 16 years - - Maximum serum creatinine (mg\u002FdL): 1.5 (Male), 1.4 (Female)\n  * Age: ≥ 16 years - Maximum serum creatinine (mg\u002FdL): 1.7 (Male), 1.4 (Female)\n\nExclusion Criteria:\n\n* Inability or unwillingness to give informed consent\u002F assent as applicable.\n* Patients with \\> Grade 2 neuropathy at the time of enrollment (participant with T-LLy only).\n* Documented malabsorption syndrome or any other condition that precludes receipt of oral medications.\n* Known HIV infection or active hepatitis B (defined as hepatitis B surface antigen-positive) or C (defined as hepatitis C antibody-positive).\n* Pregnant or lactating.\n* For patients of reproductive potential, unwillingness to use highly effective contraception for the duration of protocol therapy and for 90 days afterwards.\n* Receipt of a strong or moderate CYP3A4 inducer such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of protocol treatment.\n* Consumption of grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days of the start of protocol therapy.","ALL","1 Year","18 Years",{"count":199,"type":200},100,"ESTIMATED","INTERVENTIONAL",[203],"PHASE2","This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia.\n\nPrimary Objective\n\n* To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231.\n* To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231.\n\nSecondary Objectives\n\n* To assess the event free and overall survival of patients treated with this therapy.\n* To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.",[206,207,208],"T-cell Acute Lymphoblastic Leukemia","T-cell Lymphoma","Mixed Phenotype Acute Leukemia",[210,211,212,206,207,213],"Newly Diagnosed","Children","Young Adults","Mixed Phenotype Acute Leukemia (MPAL)","2026-04-29",{"date":216,"type":217},"2026-05-01","ACTUAL",{"date":219,"type":217},"2024-12-27",{"date":221,"type":200},"2033-12",{"name":5,"class":6},3]