[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05865301":3,"trial-entities:NCT05865301":350,"trial-summary:NCT05865301":355},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":16,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":43,"sex":53,"minimum_age":16,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":69,"locations":72,"central_contacts":343,"overall_officials":346,"references":348,"see_also_links":349},"NCT05865301","IRB-70021","Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy","RECRUITING","2038-12-31","2026-06","2026-06-04","2023-06-29","Stanford University","OTHER",true,"To use a consistent and standardized platform to retrospectively and prospectively study children and young adults with B cell malignancies receiving Immunotherapy, blinatumomab and\u002For inotuzumab ozogamicin.",null,[18],"Lymphoid Leukemia",[20,21],"PRWCC","Foresight","OBSERVATIONAL",[],{"count":25,"type":26},500,"ESTIMATED",[28],{"type":13,"name":29,"description":30,"armGroupLabels":31},"Questionnaire for patients receiving therapy","Questionnaires will be given (at baseline, 1, 3, 6, and 12 months post CAR infusion) including baseline demographics, individual\u002Ffamily and neighborhood socioeconomic data, measures of household material hardship (housing and transportation insecurity, household energy and food insecurity), barriers to care at the CAR T cell institution, as well as patient reported outcomes following Kymriah infusion.",[32,33],"Arm A (Retrospective data)","Arm B (Prospective data)",[35,39],{"measure":36,"description":37,"timeFrame":38},"WECARE-Survey","Participant will take part in a one-time questionnaire to address CAR specific questions.\n\nWECARE survey, consists of questions used to identify seven unmet material needs (education, employment, food security, housing, childcare, household heat, language)","at baseline",{"measure":40,"description":41,"timeFrame":42},"Retrospective WECARE Survey","Surveys will be administered at a single time point post-CAR","up to 12 months post infusion",[44,48,51],{"measure":45,"description":46,"timeFrame":47},"overall survival (OS)","Overall survival was the duration from the start of study treatment to death.","at baseline up to 12 months post infusion",{"measure":49,"description":50,"timeFrame":47},"event-free-survival (EFS)","probability of recurrence or progression of in patients",{"measure":52,"timeFrame":47},"duration of remission (DOR)","ALL","26 Years",false,{"inclusion":57,"exclusion":67,"raw_text":68},[58,59,60,61,62,63,64,65,66],"Experienced refractory or relapsed disease, treated with standard chemotherapy, without immunotherapy treatment.","Previously undergone standard of care immunotherapy with FDA approved therapies, such as Kymriah™ (CTL019, tisagenlecleucel), blinatumomab or","Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age.","Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma","Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age","Patients who are either:","Undergoing evaluation for leukapheresis for planned standard of care tisagenlecleucel therapy, or planned for therapy with blinatumomab or inotuzumab. (Patients who received prior tisagenlecleucel, blinatumomab or inotuzumab on an established clinical trial and are now scheduled for commercial CAR, blinatumomab or inotuzumab therapy are also eligible) Or","Experienced refractory or relapsed B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma","Ability to give informed consent. All subjects ≥ 18 years of age must be able to give informed consent or have legal authorized representative (LAR) (i.e. parent or guardian) to consent, if not in capacity to give consent independently. For subjects \\\u003C18 years old their LAR must give informed consent. Pediatric subjects will be included in age appropriate discussion and written assent will be obtained for those \\> 7 years of age, when appropriate, according to institutional procedures.",[],"Inclusion Criteria (Arm A)\n\n\\* Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma\n\nWho either:\n\n* Experienced refractory or relapsed disease, treated with standard chemotherapy, without immunotherapy treatment.\n\nOR\n\n* Previously undergone standard of care immunotherapy with FDA approved therapies, such as Kymriah™ (CTL019, tisagenlecleucel), blinatumomab or\n\n  * Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age.\n\nInclusion Criteria (Arm B)\n\n* Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma\n* Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age\n* Patients who are either:\n\n  * Undergoing evaluation for leukapheresis for planned standard of care tisagenlecleucel therapy, or planned for therapy with blinatumomab or inotuzumab. (Patients who received prior tisagenlecleucel, blinatumomab or inotuzumab on an established clinical trial and are now scheduled for commercial CAR, blinatumomab or inotuzumab therapy are also eligible) Or\n  * Experienced refractory or relapsed B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma\n* Ability to give informed consent. All subjects ≥ 18 years of age must be able to give informed consent or have legal authorized representative (LAR) (i.e. parent or guardian) to consent, if not in capacity to give consent independently. For subjects \\\u003C18 years old their LAR must give informed consent. Pediatric subjects will be included in age appropriate discussion and written assent will be obtained for those \\> 7 years of age, when appropriate, according to institutional procedures.",[70,71],"CHILD","ADULT",[73,87,99,113,124,136,148,159,171,183,195,207,219,231,243,258,272,284,296,307,319,331],{"facility":74,"status":7,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":84},"Banner University Medical Center - Tucson","Tucson","Arizona","85719","United States",[80],{"name":81,"role":82,"email":83},"Laurel Truscott","CONTACT","ltruscott@peds.arizona.edu",{"lat":85,"lon":86},32.22174,-110.92648,{"facility":88,"status":7,"city":89,"state":90,"zip":91,"country":78,"contacts":92,"geoPoint":96},"City of Hope Comprehensive Cancer Center","Duarte","California","91010",[93],{"name":94,"role":82,"email":95},"Lindsey Murphy","lmurphy@coh.org",{"lat":97,"lon":98},34.13945,-117.97729,{"facility":12,"status":7,"city":100,"state":90,"zip":101,"country":78,"contacts":102,"geoPoint":110},"Palo Alto","94305",[103,107],{"name":104,"role":82,"phone":105,"email":106},"Khanh Nguyen","650-721-2372","khanhpn@stanford.edu",{"name":108,"role":109},"Kara Davis, MD","PRINCIPAL_INVESTIGATOR",{"lat":111,"lon":112},37.44188,-122.14302,{"facility":114,"status":7,"city":115,"state":90,"zip":116,"country":78,"contacts":117,"geoPoint":121},"UCSF (Benioff Children's)","San Francisco","94115",[118],{"name":119,"role":82,"email":120},"William Temple","william.temple@ucsf.edu",{"lat":122,"lon":123},37.77493,-122.41942,{"facility":125,"status":7,"city":126,"state":127,"zip":128,"country":78,"contacts":129,"geoPoint":133},"Nemours Children's Hospital","New Castle","Delaware","19803",[130],{"name":131,"role":82,"email":132},"Ellen Fraint","Ellen.Fraint@nemours.org",{"lat":134,"lon":135},39.65948,-75.56359,{"facility":137,"status":7,"city":138,"state":139,"zip":140,"country":78,"contacts":141,"geoPoint":145},"University of Florida Health Science Center - Gainesville","Gainesville","Florida","32610",[142],{"name":143,"role":82,"email":144},"John Ligon","john.ligon@ufl.edu",{"lat":146,"lon":147},29.65163,-82.32483,{"facility":149,"status":7,"city":150,"state":139,"zip":151,"country":78,"contacts":152,"geoPoint":156},"Johns Hopkins All Children's Hospital","St. Petersburg","33701",[153],{"name":154,"role":82,"email":155},"Natalie Booth","nbooth3@jh.edu",{"lat":157,"lon":158},27.77086,-82.67927,{"facility":160,"status":7,"city":161,"state":162,"zip":163,"country":78,"contacts":164,"geoPoint":168},"Ann & Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",[165],{"name":166,"role":82,"email":167},"Kevin McNerney","kmcnerney@luriechildrens.org",{"lat":169,"lon":170},41.85003,-87.65005,{"facility":172,"status":7,"city":173,"state":174,"zip":175,"country":78,"contacts":176,"geoPoint":180},"Johns Hopkins University\u002FSidney Kimmel Cancer Center","Baltimore","Maryland","21231",[177],{"name":178,"role":82,"email":179},"Stacy Cooper","scoope30@jhmi.edu",{"lat":181,"lon":182},39.29038,-76.61219,{"facility":184,"status":7,"city":185,"state":186,"zip":187,"country":78,"contacts":188,"geoPoint":192},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",[189],{"name":190,"role":82,"email":191},"Susanne Baumeister","susanne_baumeister@dfci.harvard.edu",{"lat":193,"lon":194},42.35843,-71.05977,{"facility":196,"status":7,"city":197,"state":198,"zip":199,"country":78,"contacts":200,"geoPoint":204},"Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital","Grand Rapids","Michigan","49503",[201],{"name":202,"role":82,"email":203},"Troy Quigg","troy.quigg@corewellhealth.org;",{"lat":205,"lon":206},42.96336,-85.66809,{"facility":208,"status":7,"city":209,"state":210,"zip":211,"country":78,"contacts":212,"geoPoint":216},"St. Louis Children's (Washington University)","St Louis","Missouri","63110",[213],{"name":214,"role":82,"email":215},"Thomas Pfeiffer","pthomas@wustl.edu",{"lat":217,"lon":218},38.62727,-90.19789,{"facility":220,"status":7,"city":221,"state":222,"zip":223,"country":78,"contacts":224,"geoPoint":228},"Children's Hospital at Montefiore","The Bronx","New York","10467",[225],{"name":226,"role":82,"email":227},"David Loeb","david.loeb@einsteinmed.edu",{"lat":229,"lon":230},40.84985,-73.86641,{"facility":232,"status":7,"city":233,"state":234,"zip":235,"country":78,"contacts":236,"geoPoint":240},"Atrium Health Levine Cancer Institute","Charlotte","North Carolina","28262",[237],{"name":238,"role":82,"email":239},"Jeffrey Huo","Jeffrey.Huo@atriumhealth.org",{"lat":241,"lon":242},35.22709,-80.84313,{"facility":244,"status":7,"city":245,"state":246,"zip":247,"country":78,"contacts":248,"geoPoint":255},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",[249,252],{"name":250,"role":82,"email":251},"Christine Phillips","christine.phillips@cchmc.org",{"name":253,"role":82,"email":254},"Christa Krupski","christa.krupski@cchmc.org",{"lat":256,"lon":257},39.12711,-84.51439,{"facility":259,"status":7,"city":260,"state":261,"zip":262,"country":78,"contacts":263,"geoPoint":269},"OHSU Knight Cancer Institute","Portland","Oregon","97239",[264,267],{"name":265,"role":82,"email":266},"Bill Chang, MD","changb@ohsu.edu",{"name":268,"role":109},"BIll Chang, MD",{"lat":270,"lon":271},45.52345,-122.67621,{"facility":273,"status":7,"city":274,"state":275,"zip":276,"country":78,"contacts":277,"geoPoint":281},"Children's Hospital of Pittsburgh of UPMC","Pittsburgh","Pennsylvania","15224",[278],{"name":279,"role":82,"email":280},"Randy Windreich","Randy.Windreich@chp.edu",{"lat":282,"lon":283},40.44062,-79.99589,{"facility":285,"status":7,"city":286,"state":287,"zip":288,"country":78,"contacts":289,"geoPoint":293},"UT Southwestern\u002FSimmons Cancer Center-Dallas","Dallas","Texas","75235",[290],{"name":291,"role":82,"email":292},"Samuel John","samuel.john@utsouthwestern.edu",{"lat":294,"lon":295},32.78306,-96.80667,{"facility":297,"status":7,"city":298,"state":287,"zip":299,"country":78,"contacts":300,"geoPoint":304},"Cook Children's Medical Center","Fort Worth","76104",[301],{"name":302,"role":82,"email":303},"Holly Pacenta","holly.pacenta@cookchildrens.org",{"lat":305,"lon":306},32.72541,-97.32085,{"facility":308,"status":7,"city":309,"state":310,"zip":311,"country":78,"contacts":312,"geoPoint":316},"Saint Jude Children's Research Hospital","Fairfax","Virginia","22203",[313],{"name":314,"role":82,"email":315},"Swati Naik","swati.naik@stjude.org",{"lat":317,"lon":318},38.84622,-77.30637,{"facility":320,"status":7,"city":321,"state":322,"zip":323,"country":78,"contacts":324,"geoPoint":328},"Seattle Children's Hospital","Seattle","Washington","98105",[325],{"name":326,"role":82,"email":327},"Anurekha Hall","Anurekha.Hall@seattlechildrens.org",{"lat":329,"lon":330},47.60621,-122.33207,{"facility":332,"status":7,"city":333,"state":334,"zip":335,"country":78,"contacts":336,"geoPoint":340},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226",[337],{"name":338,"role":82,"email":339},"Amy Moskop","amoskop@mcw.edu",{"lat":341,"lon":342},43.0389,-87.90647,[344],{"name":104,"role":82,"phone":345,"email":106},"(650) 721-2372",[347],{"name":108,"affiliation":12,"role":109},[],[],{"nct_id":4,"conditions":351,"biomarkers":354},[352,353],"B-Cell Non-Hodgkin Lymphoma","Precursor B-cell acute lymphoblastic leukemia",[],{"nct_id":4,"found":14,"summary":356,"prompt_version":366},{"design":357,"status":358,"heading":359,"summary":360,"follow_up":361,"word_count":362,"commitments":363,"compensation":364,"drugs_mentioned":365},"This is an observational study, meaning researchers will collect information without giving new treatments. It plans to include up to 500 participants.","completed","Observational Study of Immunotherapy for Pediatric and Young Adult B-Cell Malignancies","This observational study is looking at how children and young adults (up to age 26) with B-cell malignancies (cancers of certain white blood cells) respond to immunotherapy treatments like Kymriah™ (tisagenlecleucel), blinatumomab, and inotuzumab ozogamicin. The study aims to understand the real-world outcomes for patients receiving these commercially available therapies. You might be able to join if you have B-cell precursor acute lymphoblastic leukemia (ALL) or B-cell lymphoma that has come back or didn't respond to standard chemotherapy, or if you've already received one of these immunotherapy treatments. Researchers will use questionnaires to gather information about your health and social factors. The main goal is to see how patients are doing at the start of treatment and up to 12 months afterward. The current recruitment status is unclear.","Participants will be followed for up to 12 months after their immunotherapy infusion.",128,"You would complete questionnaires at the start of treatment, and then at 1, 3, 6, and 12 months after receiving your CAR T-cell infusion.","Not stated in the trial record.",[],"v2"]