[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437182":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":21,"centralContacts":30,"locations":41,"responsibleParty":237,"collaborators":35,"id":239,"slug":240,"hasResults":241,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":241,"sex":247,"minAge":35,"maxAge":248,"enrollmentInfo":249,"targetDuration":35,"studyType":252,"phases":253,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":52,"whyStopped":35,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":273},{"fullName":5,"class":6},"New York Medical College","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Interventional","Phase 1: 3 dose levels to determine safety (15 patients)\n\nDose expansion:\n\nDaratumumab (DARA) treatment post-HCT\n\n1. Induction: DARA IV weekly x 8 doses (Weeks 1-8)\n2. Consolidation: DARA IV every 2 weeks x 8 doses (Weeks 9-24)\n3. Maintenance: DARA IV every 4 weeks (Stop at Day +270)",[12],"Drug: Daratumumab",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Daratumumab","Total body irradiation (TBI)-based myeloablative allogeneic hematopoietic stem cell transplantation (HCT) using best available donor.\n\nDaratumumab (DARA) treatment post-HCT Phase 1: 3 dose levels to determine safety (15 patients)\n\nDose expansion:\n\n1. Induction: DARA IV weekly x 8 doses (Weeks 1-8)\n2. Consolidation: DARA every 2 weeks x 8 doses (Weeks 9-24)\n3. Maintenance: DARA every 4 weeks (Stop at Day +270)",[9],[20],"Darzalex®",[22,25,28],{"name":23,"affiliation":5,"role":24},"Mitchell Cairo, MD","STUDY_CHAIR",{"name":26,"affiliation":27,"role":24},"Troy Quigg, DO","Helen DeVos Children's Hospital",{"name":29,"affiliation":5,"role":24},"Allyson Flower, MD",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Lauren Harrison, RN, MSN","CONTACT","6172857844",null,"lauren_harrison@nymc.edu",{"name":38,"role":33,"phone":39,"phoneExt":35,"email":40},"Erin Morris, RN","7149645359","erin_morris@nymc.edu",[42,50,67,81,89,104,119,129,138,153,168,181,192,202,217,227],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":35,"geoPoint":35,"contacts":35},"Phoenix Children's Hospital","NOT_YET_RECRUITING","Phoeniz","Arizona","85016","United States","US",{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":48,"countryCode":49,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Loma Linda University Children's Hospital","RECRUITING","Loma Linda","California","92354",{"type":57,"coordinates":58},"Point",[59,60],-117.26115,34.04835,{"lat":60,"lon":59},[63],{"name":64,"role":33,"phone":65,"phoneExt":35,"email":66},"Hisham Abdel-Azim, MD","(909) 558-4076","habdelazim@llu.edu",{"facility":68,"status":44,"city":69,"state":54,"zip":70,"country":48,"countryCode":49,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"University of California","Los Angeles","90095",{"type":57,"coordinates":72},[73,74],-118.24368,34.05223,{"lat":74,"lon":73},[77],{"name":78,"role":33,"phone":79,"phoneExt":35,"email":80},"Ted Moore, MD","(310) 825-6708","TBMoore@mednet.ucla.edu",{"facility":68,"status":52,"city":82,"state":54,"zip":83,"country":48,"countryCode":49,"cosmosGeoPoint":84,"geoPoint":88,"contacts":35},"San Francisco","94143",{"type":57,"coordinates":85},[86,87],-122.41942,37.77493,{"lat":87,"lon":86},{"facility":90,"status":44,"city":91,"state":92,"zip":93,"country":48,"countryCode":49,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Children's Hospital Colordao","Aurora","Colorado","80045",{"type":57,"coordinates":95},[96,97],-104.83192,39.72943,{"lat":97,"lon":96},[100],{"name":101,"role":33,"phone":102,"phoneExt":35,"email":103},"Taymour Hammoudi, MD","(720) 777-8563","taymour.hammoudi@cuanschutz.edu",{"facility":105,"status":44,"city":106,"state":107,"zip":108,"country":48,"countryCode":49,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Children's National Medical Center","Washington D.C.","District of Columbia","20010",{"type":57,"coordinates":110},[111,112],-77.03637,38.89511,{"lat":112,"lon":111},[115],{"name":116,"role":33,"phone":117,"phoneExt":35,"email":118},"Anant Vatsayan, MBBS","(202) 476-4840","avatsayan@childrensnational.org",{"facility":120,"status":52,"city":121,"state":122,"zip":123,"country":48,"countryCode":49,"cosmosGeoPoint":35,"geoPoint":35,"contacts":124},"University of Florida","Gainsville","Florida","32608",[125],{"name":126,"role":33,"phone":127,"phoneExt":35,"email":128},"Jordan Milner, MD","(352) 273-9120","jordan.milner@peds.ufl.edu",{"facility":130,"status":44,"city":131,"state":122,"zip":132,"country":48,"countryCode":49,"cosmosGeoPoint":133,"geoPoint":137,"contacts":35},"John Hopkins All Children's Hospital","St. Petersburg","33701",{"type":57,"coordinates":134},[135,136],-82.67927,27.77086,{"lat":136,"lon":135},{"facility":139,"status":52,"city":140,"state":141,"zip":142,"country":48,"countryCode":49,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Riley Children's Hospital","Indianapolis","Indiana","46202",{"type":57,"coordinates":144},[145,146],-86.15804,39.76838,{"lat":146,"lon":145},[149],{"name":150,"role":33,"phone":151,"phoneExt":35,"email":152},"April Rahrig, MD","(260) 227-0353","alrahrig@iu.edu",{"facility":154,"status":52,"city":155,"state":156,"zip":157,"country":48,"countryCode":49,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":57,"coordinates":159},[160,161],-71.05977,42.35843,{"lat":161,"lon":160},[164],{"name":165,"role":33,"phone":166,"phoneExt":35,"email":167},"Amy Keating, MD","(857) 215-2881","amy_keating@dfci.harvard.edu",{"facility":27,"status":52,"city":169,"state":170,"zip":171,"country":48,"countryCode":49,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Grand Rapids","Michigan","49503",{"type":57,"coordinates":173},[174,175],-85.66809,42.96336,{"lat":175,"lon":174},[178],{"name":26,"role":33,"phone":179,"phoneExt":35,"email":180},"(616) 391-3962","troy.quigg@corewellhealth.org",{"facility":5,"status":52,"city":182,"state":183,"zip":184,"country":48,"countryCode":49,"cosmosGeoPoint":35,"geoPoint":35,"contacts":185},"Vallhala","New York","10595",[186,189],{"name":23,"role":33,"phone":187,"phoneExt":35,"email":188},"914-594-3650","mitchell_cairo@nymc.edu",{"name":190,"role":33,"phone":191,"phoneExt":35,"email":36},"Lauren Harrison, MSN","617-285-7844",{"facility":193,"status":44,"city":194,"state":195,"zip":196,"country":48,"countryCode":49,"cosmosGeoPoint":197,"geoPoint":201,"contacts":35},"Nationwide Children's Hosptial","Columbus","Ohio","43205",{"type":57,"coordinates":198},[199,200],-82.99879,39.96118,{"lat":200,"lon":199},{"facility":203,"status":52,"city":204,"state":205,"zip":206,"country":48,"countryCode":49,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":57,"coordinates":208},[209,210],-75.16362,39.95238,{"lat":210,"lon":209},[213],{"name":214,"role":33,"phone":215,"phoneExt":35,"email":216},"Alix Seif, MD","(215) 590-9996","seifa@chop.edu",{"facility":218,"status":44,"city":219,"state":220,"zip":221,"country":48,"countryCode":49,"cosmosGeoPoint":222,"geoPoint":226,"contacts":35},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":57,"coordinates":223},[224,225],-95.36327,29.76328,{"lat":225,"lon":224},{"facility":228,"status":44,"city":229,"state":230,"zip":231,"country":48,"countryCode":49,"cosmosGeoPoint":232,"geoPoint":236,"contacts":35},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":57,"coordinates":233},[234,235],-87.90647,43.0389,{"lat":235,"lon":234},{"type":238,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100437182","phase-1-targeted-immunotherapy-after-myeloablative-tbi-based-conditioning--allohct-in-caya-with-high-risk-t-cell-all--lymphoma-100437182",false,"NCT04972942","Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma","Phase I Trial of Targeted Immunotherapy With Daratumumab Following Myeloablative TBI-Based Conditioning and AlloHCT in Children, Adolescents and Young Adults With High Risk T-Cell Acute Lymphoblastic Leukemia and Lymphoma (ALLO-T-DART)","ALLO-T-DART","Inclusion Criteria:\n\n* 0-39yrs\n* T-cell ALL in second or subsequent remission (≤ 5% blasts) or relapsed T-cell LLy with complete response after re-induction therapy (including secondary malignancy)\n* Planned allogeneic stem cell transplantation with donor identified\n* Performance status ≥ 60%\n* Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\n* Meet organ function requirements\n* Signed IRB approved informed consent\n\nExclusion Criteria:\n\n* May not have had a prior autologous or allogenic stem cell transplant\n* May not have uncontrolled, systemic infection at the time of enrollment\n* Known allergies, hypersensitivity, or intolerance to mannitol, sorbitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients\n* Must not be pregnant or actively breast feeding\n* Seropositive for HIV, hepatitis B or hepatitis C\n* COPD\n* Asthma\n* Clinically significant cardiac disease","ALL","39 Years",{"count":250,"type":251},30,"ESTIMATED","INTERVENTIONAL",[254],"PHASE1","A Phase I trial to determine the safety of targeted immunotherapy with daratumumab (DARA) IV after total body irradiation (TBI)-based myeloablative conditioning and allogeneic hematopoietic cell transplantation (HCT) for children, adolescents, and young adults (CAYA) with high risk T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LLy).\n\nPre- and post-HCT NGS-MRD studies will be correlated with outcomes in children, adolescents, and young adults with T-ALL undergoing allogeneic HCT and post-HCT DARA treatment. The study will also evaluate T-cell repertoire and immune reconstitution prior to and following DARA post-HCT treatment and correlate with patient outcomes.",[257,258],"T-cell Acute Lymphoblastic Leukemia","T-Cell Acute Lymphoblastic Lymphoma",[260,261,262,263],"immunotherapy","children","adolescents","young adults","2026-04-10",{"date":266,"type":267},"2026-04-15","ACTUAL",{"date":269,"type":267},"2023-05-22",{"date":271,"type":251},"2028-09",{"name":5,"class":6},16]