[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504467":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":59,"centralContacts":63,"locations":68,"responsibleParty":468,"collaborators":472,"id":488,"slug":489,"hasResults":490,"nctId":491,"briefTitle":492,"officialTitle":492,"acronym":28,"eligibilityCriteria":493,"healthyVolunteers":490,"sex":494,"minAge":28,"maxAge":495,"enrollmentInfo":496,"targetDuration":28,"studyType":499,"phases":500,"briefSummary":503,"conditions":504,"keywords":28,"overallStatus":71,"whyStopped":28,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":515},{"fullName":5,"class":6},"Stanford University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance.\n\nInterventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib",[13,14,15,16,17,18,19,20,21],"Drug: Dexamethasone","Drug: Mitoxantrone","Drug: PEG asparaginase","Drug: Bortezomib","Drug: Vorinostat","Drug: Mercaptopurine","Drug: Methotrexate","Drug: Blinatumomab","Drug: Ziftomenib",[23,29,33,36,39,43,47,51,55],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Dexamethasone","Given orally (PO) or naso-gastrically (NG) or intravenously (IV).",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Mitoxantrone","Given IV",[9],{"type":24,"name":34,"description":31,"armGroupLabels":35,"otherNames":28},"PEG asparaginase",[9],{"type":24,"name":37,"description":31,"armGroupLabels":38,"otherNames":28},"Bortezomib",[9],{"type":24,"name":40,"description":41,"armGroupLabels":42,"otherNames":28},"Vorinostat","Taken PO or NG",[9],{"type":24,"name":44,"description":45,"armGroupLabels":46,"otherNames":28},"Mercaptopurine","Given PO or NG.",[9],{"type":24,"name":48,"description":49,"armGroupLabels":50,"otherNames":28},"Methotrexate","Given IV, IM or PO",[9],{"type":24,"name":52,"description":53,"armGroupLabels":54,"otherNames":28},"Blinatumomab","Will be administered at 15 mcg\u002Fm2\u002Fday for 28 days following induction and reinduction",[9],{"type":24,"name":56,"description":57,"armGroupLabels":58,"otherNames":28},"Ziftomenib","3+3 dose escalation will be done. Dose level 1 will start at 75% of the adult recommended phase two dosing which has been established in phase I studies. Based on tolerability, we will either de-escalate to 50% RP2D (dose level -1) or escalate to 100% RP2D",[9],[60],{"name":61,"affiliation":5,"role":62},"Tanja A Gruber, MD, PhD","PRINCIPAL_INVESTIGATOR",[64],{"name":61,"role":65,"phone":66,"phoneExt":28,"email":67},"CONTACT","650 723 5535","tagruber@stanford.edu",[69,90,106,126,141,160,170,186,207,227,242,258,275,292,307,323,340,358,377,393,409,425,441,453],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Phoenix Children's Hospital","RECRUITING","Phoenix","Arizona","85016","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-112.07404,33.44838,{"lat":81,"lon":80},[84,88],{"name":85,"role":65,"phone":86,"phoneExt":28,"email":87},"Chris Oless, RN","602-933-0920","coless@phoenixchildrens.com",{"name":89,"role":62,"phone":28,"phoneExt":28,"email":28},"Dana Salzberg, 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McCall, MD","717-792-6604","dmccall1@mdanderson.org",{"facility":308,"status":71,"city":309,"state":295,"zip":310,"country":75,"countryCode":76,"cosmosGeoPoint":311,"geoPoint":315,"contacts":316},"University of Texas Health Science Center San Antonio","San Antonio","78229",{"type":78,"coordinates":312},[313,314],-98.49363,29.42412,{"lat":314,"lon":313},[317,321],{"name":318,"role":65,"phone":319,"phoneExt":28,"email":320},"Jaclyn Hung Y Hung, PhD","210-567-7477","hungj@uthscsa.edu",{"name":322,"role":62,"phone":28,"phoneExt":28,"email":28},"Anne-Marie Langevin, MD",{"facility":324,"status":71,"city":325,"state":326,"zip":327,"country":75,"countryCode":76,"cosmosGeoPoint":328,"geoPoint":332,"contacts":333},"University of Utah Huntsman Cancer Institute","Salt Lake City","Utah","84108",{"type":78,"coordinates":329},[330,331],-111.89105,40.76078,{"lat":331,"lon":330},[334,338],{"name":335,"role":65,"phone":336,"phoneExt":28,"email":337},"David S Mangum, MD","801-662-4700","Spencer.Mangum@hsc.utah.edu",{"name":339,"role":62,"phone":28,"phoneExt":28,"email":28},"David Mangum, MD",{"facility":341,"status":71,"city":342,"state":343,"zip":344,"country":75,"countryCode":76,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"Children's Hospital of The King's Daughters","Norfolk","Virginia","23507",{"type":78,"coordinates":346},[347,348],-76.28522,36.84681,{"lat":348,"lon":347},[351,355,357],{"name":352,"role":65,"phone":353,"phoneExt":28,"email":354},"Eric Lowe, MD","757-668-7243","Eric.Lowe@chkd.org",{"name":28,"role":65,"phone":28,"phoneExt":28,"email":356},"ccbdcresearch@chkd.org",{"name":352,"role":62,"phone":28,"phoneExt":28,"email":28},{"facility":359,"status":172,"city":360,"state":361,"zip":362,"country":363,"countryCode":364,"cosmosGeoPoint":365,"geoPoint":369,"contacts":370},"Alberta Children's Hospital","Calgary","Alberta","T3B 6A8","Canada","CA",{"type":78,"coordinates":366},[367,368],-114.08529,51.05011,{"lat":368,"lon":367},[371,375],{"name":372,"role":65,"phone":373,"phoneExt":28,"email":374},"Victor Lewis","1-403-955-7203","Victor.Lewis@albertahealthservices.ca",{"name":376,"role":62,"phone":28,"phoneExt":28,"email":28},"Victor Lewis, MD",{"facility":378,"status":172,"city":379,"state":361,"zip":380,"country":363,"countryCode":364,"cosmosGeoPoint":381,"geoPoint":385,"contacts":386},"Stollery Children's Hospital","Edmonton","T6G 2B7",{"type":78,"coordinates":382},[383,384],-113.46871,53.55014,{"lat":384,"lon":383},[387,391],{"name":388,"role":65,"phone":389,"phoneExt":28,"email":390},"Sunil Desai","1-780-407-8798","Sunil.Desai@albertahealthservices.ca",{"name":392,"role":62,"phone":28,"phoneExt":28,"email":28},"Sunil J Desai, MD",{"facility":394,"status":172,"city":395,"state":396,"zip":397,"country":363,"countryCode":364,"cosmosGeoPoint":398,"geoPoint":402,"contacts":403},"BC Children's Hospital","Vancouver","British Columbia","V6H 3V4",{"type":78,"coordinates":399},[400,401],-123.11934,49.24966,{"lat":401,"lon":400},[404,408],{"name":405,"role":65,"phone":406,"phoneExt":28,"email":407},"Amanda Li, MD","1-604-875-2345","ali3@cw.bc.ca",{"name":405,"role":62,"phone":28,"phoneExt":28,"email":28},{"facility":410,"status":172,"city":411,"state":412,"zip":413,"country":363,"countryCode":364,"cosmosGeoPoint":414,"geoPoint":418,"contacts":419},"McMaster Children's Hospital","Hamilton","Ontario","L8N 3Z5",{"type":78,"coordinates":415},[416,417],-79.84963,43.25011,{"lat":417,"lon":416},[420,424],{"name":421,"role":65,"phone":422,"phoneExt":28,"email":423},"Uma Athale, MD","1-905-525-9140","athaleu@mcmaster.ca",{"name":421,"role":62,"phone":28,"phoneExt":28,"email":28},{"facility":426,"status":172,"city":427,"state":428,"zip":429,"country":363,"countryCode":364,"cosmosGeoPoint":430,"geoPoint":434,"contacts":435},"CHU Sainte-Justine","Montreal","Quebec","H3T 1C5",{"type":78,"coordinates":431},[432,433],-73.58781,45.50884,{"lat":433,"lon":432},[436,440],{"name":437,"role":65,"phone":438,"phoneExt":28,"email":439},"Thai Hoa Tran, MD","1-514-345-4931","thaihoa.tran@recherchestejustine.qc.ca",{"name":437,"role":62,"phone":28,"phoneExt":28,"email":28},{"facility":442,"status":172,"city":427,"state":428,"zip":443,"country":363,"countryCode":364,"cosmosGeoPoint":444,"geoPoint":446,"contacts":447},"Montreal Children's Hospital","H4A 3J1",{"type":78,"coordinates":445},[432,433],{"lat":433,"lon":432},[448,452],{"name":449,"role":65,"phone":450,"phoneExt":28,"email":451},"Stephanie Mourad, MD","1-514-412-4400","stephanie.mourad@mcgill.ca",{"name":449,"role":62,"phone":28,"phoneExt":28,"email":28},{"facility":454,"status":172,"city":455,"state":428,"zip":456,"country":363,"countryCode":364,"cosmosGeoPoint":457,"geoPoint":461,"contacts":462},"Chu De Quebec","Québec","G1V 4G2",{"type":78,"coordinates":458},[459,460],-71.21454,46.81228,{"lat":460,"lon":459},[463,467],{"name":464,"role":65,"phone":465,"phoneExt":28,"email":466},"Bruno Michon, MD","1-418-654-2158","bruno.michon.med@ssss.gouv.qc.ca",{"name":464,"role":62,"phone":28,"phoneExt":28,"email":28},{"type":469,"investigatorFullName":470,"investigatorTitle":471,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Tanja Andrea Gruber","Faculty - Hematology\u002FOncology",[473,475,478,481,483,486],{"name":474,"class":6},"The Pediatric Oncology Experimental Therapeutics Investigators' Consortium",{"name":476,"class":477},"Amgen","INDUSTRY",{"name":479,"class":480},"Lucile Packard Foundation for Children's Health","UNKNOWN",{"name":482,"class":477},"Kura Oncology, Inc.",{"name":484,"class":485},"United States Department of Defense","FED",{"name":487,"class":480},"Cannonball Kid's Cancer","100504467","phase-1-tini-2-total-therapy-for-infants-with-acute-lymphoblastic-leukemia-ii-100504467",false,"NCT05848687","TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II","Inclusion Criteria:\n\n* Patient is ≤ 365 days of age at the time of diagnosis.\n* Patient has newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia. Subjects with bilineage or biphenotypic acute leukemia are eligible provided they express CD19. Patients with CD19 positive mature B-cell ALL who carry a KMT2A rearrangement are eligible.\n* Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, cytarabine for 72 hours or less, one dose of vincristine, and one dose of intrathecal chemotherapy.\n* Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.\n\nExclusion Criteria:\n\n* Patients with prior therapy, other than therapy specified in inclusion criteria.\n* Patients with mature B-cell ALL that do not have a KMT2A rearrangement or patients with acute myelogenous (AML) or T-cell ALL.\n* Patients with Down syndrome.\n* Inability or unwillingness of legal guardian\u002Frepresentative to give written informed consent","ALL","1 Year",{"count":497,"type":498},90,"ESTIMATED","INTERVENTIONAL",[501,502],"PHASE1","PHASE2","The purpose of this study is to improve upon the TINI study treatment. The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.",[505],"Lymphoblastic Leukemia","2026-05-31",{"date":508,"type":509},"2026-06-03","ACTUAL",{"date":511,"type":509},"2023-11-03",{"date":513,"type":498},"2033-12",{"name":470,"class":6},24]