[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437182":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":21,"centralContacts":30,"locations":41,"responsibleParty":236,"collaborators":35,"id":238,"slug":35,"hasResults":239,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":239,"sex":245,"minAge":35,"maxAge":246,"enrollmentInfo":247,"targetDuration":35,"studyType":250,"phases":251,"briefSummary":253,"conditions":254,"keywords":257,"overallStatus":51,"whyStopped":35,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},{"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",[42,49,66,80,88,103,118,128,137,152,167,180,191,201,216,226],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"cosmosGeoPoint":35,"geoPoint":35,"contacts":35},"Phoenix Children's Hospital","NOT_YET_RECRUITING","Phoeniz","Arizona","85016","United States",{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":48,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Loma Linda University Children's Hospital","RECRUITING","Loma Linda","California","92354",{"type":56,"coordinates":57},"Point",[58,59],-117.26115,34.04835,{"lat":59,"lon":58},[62],{"name":63,"role":33,"phone":64,"phoneExt":35,"email":65},"Hisham Abdel-Azim, MD","(909) 558-4076","habdelazim@llu.edu",{"facility":67,"status":44,"city":68,"state":53,"zip":69,"country":48,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"University of California","Los Angeles","90095",{"type":56,"coordinates":71},[72,73],-118.24368,34.05223,{"lat":73,"lon":72},[76],{"name":77,"role":33,"phone":78,"phoneExt":35,"email":79},"Ted Moore, MD","(310) 825-6708","TBMoore@mednet.ucla.edu",{"facility":67,"status":51,"city":81,"state":53,"zip":82,"country":48,"cosmosGeoPoint":83,"geoPoint":87,"contacts":35},"San Francisco","94143",{"type":56,"coordinates":84},[85,86],-122.41942,37.77493,{"lat":86,"lon":85},{"facility":89,"status":44,"city":90,"state":91,"zip":92,"country":48,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Children's Hospital Colordao","Aurora","Colorado","80045",{"type":56,"coordinates":94},[95,96],-104.83192,39.72943,{"lat":96,"lon":95},[99],{"name":100,"role":33,"phone":101,"phoneExt":35,"email":102},"Taymour Hammoudi, MD","(720) 777-8563","taymour.hammoudi@cuanschutz.edu",{"facility":104,"status":44,"city":105,"state":106,"zip":107,"country":48,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Children's National Medical Center","Washington D.C.","District of Columbia","20010",{"type":56,"coordinates":109},[110,111],-77.03637,38.89511,{"lat":111,"lon":110},[114],{"name":115,"role":33,"phone":116,"phoneExt":35,"email":117},"Anant Vatsayan, MBBS","(202) 476-4840","avatsayan@childrensnational.org",{"facility":119,"status":51,"city":120,"state":121,"zip":122,"country":48,"cosmosGeoPoint":35,"geoPoint":35,"contacts":123},"University of Florida","Gainsville","Florida","32608",[124],{"name":125,"role":33,"phone":126,"phoneExt":35,"email":127},"Jordan Milner, MD","(352) 273-9120","jordan.milner@peds.ufl.edu",{"facility":129,"status":44,"city":130,"state":121,"zip":131,"country":48,"cosmosGeoPoint":132,"geoPoint":136,"contacts":35},"John Hopkins All Children's Hospital","St. Petersburg","33701",{"type":56,"coordinates":133},[134,135],-82.67927,27.77086,{"lat":135,"lon":134},{"facility":138,"status":51,"city":139,"state":140,"zip":141,"country":48,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Riley Children's Hospital","Indianapolis","Indiana","46202",{"type":56,"coordinates":143},[144,145],-86.15804,39.76838,{"lat":145,"lon":144},[148],{"name":149,"role":33,"phone":150,"phoneExt":35,"email":151},"April Rahrig, MD","(260) 227-0353","alrahrig@iu.edu",{"facility":153,"status":51,"city":154,"state":155,"zip":156,"country":48,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":56,"coordinates":158},[159,160],-71.05977,42.35843,{"lat":160,"lon":159},[163],{"name":164,"role":33,"phone":165,"phoneExt":35,"email":166},"Amy Keating, MD","(857) 215-2881","amy_keating@dfci.harvard.edu",{"facility":27,"status":51,"city":168,"state":169,"zip":170,"country":48,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Grand Rapids","Michigan","49503",{"type":56,"coordinates":172},[173,174],-85.66809,42.96336,{"lat":174,"lon":173},[177],{"name":26,"role":33,"phone":178,"phoneExt":35,"email":179},"(616) 391-3962","troy.quigg@corewellhealth.org",{"facility":5,"status":51,"city":181,"state":182,"zip":183,"country":48,"cosmosGeoPoint":35,"geoPoint":35,"contacts":184},"Vallhala","New York","10595",[185,188],{"name":23,"role":33,"phone":186,"phoneExt":35,"email":187},"914-594-3650","mitchell_cairo@nymc.edu",{"name":189,"role":33,"phone":190,"phoneExt":35,"email":36},"Lauren Harrison, MSN","617-285-7844",{"facility":192,"status":44,"city":193,"state":194,"zip":195,"country":48,"cosmosGeoPoint":196,"geoPoint":200,"contacts":35},"Nationwide Children's Hosptial","Columbus","Ohio","43205",{"type":56,"coordinates":197},[198,199],-82.99879,39.96118,{"lat":199,"lon":198},{"facility":202,"status":51,"city":203,"state":204,"zip":205,"country":48,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":56,"coordinates":207},[208,209],-75.16362,39.95238,{"lat":209,"lon":208},[212],{"name":213,"role":33,"phone":214,"phoneExt":35,"email":215},"Alix Seif, MD","(215) 590-9996","seifa@chop.edu",{"facility":217,"status":44,"city":218,"state":219,"zip":220,"country":48,"cosmosGeoPoint":221,"geoPoint":225,"contacts":35},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":56,"coordinates":222},[223,224],-95.36327,29.76328,{"lat":224,"lon":223},{"facility":227,"status":44,"city":228,"state":229,"zip":230,"country":48,"cosmosGeoPoint":231,"geoPoint":235,"contacts":35},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":56,"coordinates":232},[233,234],-87.90647,43.0389,{"lat":234,"lon":233},{"type":237,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","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":248,"type":249},30,"ESTIMATED","INTERVENTIONAL",[252],"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.",[255,256],"T-cell Acute Lymphoblastic Leukemia","T-Cell Acute Lymphoblastic Lymphoma",[258,259,260,261],"immunotherapy","children","adolescents","young adults","2026-04-10",{"date":264,"type":265},"2026-04-15","ACTUAL",{"date":267,"type":265},"2023-05-22",{"date":269,"type":249},"2028-09",{"name":5,"class":6},16]