[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629596":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":41,"centralContacts":46,"locations":53,"responsibleParty":367,"collaborators":51,"id":370,"slug":371,"hasResults":372,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":51,"eligibilityCriteria":376,"healthyVolunteers":372,"sex":377,"minAge":378,"maxAge":51,"enrollmentInfo":379,"targetDuration":51,"studyType":382,"phases":383,"briefSummary":385,"conditions":386,"keywords":388,"overallStatus":390,"whyStopped":51,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":400},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"SR induction","ACTIVE_COMPARATOR","prospective, randomized 1:1, open label phase II\u002FIII trial comparing arm AI (ALLR3-MITOX) versus arm BI (InO). Randomization is stratified according to frontline treatment group (BFM, AIEOP, ALLTogether, other) and localization of relapse (BM+CNS, other)",[13],"Drug: Inotuzumab ozogamicin (INO)",{"label":15,"type":10,"description":16,"interventionNames":17},"SR MRD good response, consolidation","single arm trial with 3 courses of blinatumomab, the 1st replacing the consolidation chemotherapy element SCB2, the 2nd added on after the consolidation chemotherapy element SCB3, and the 3rd added on after the consolidation element SCB4 and 8 weeks of conventional maintenance therapy, then followed by conventional maintenance therapy being applied without reinduction chemotherapy pulses until week 132, as compared to historical controls (IntReALL BCP 2020 SR SOC induction arm compared with IntReALL SR 2010 arm B without epratuzumab)",[18],"Drug: Blinatumomab",{"label":20,"type":10,"description":21,"interventionNames":22},"HR with CR2, consolidation","single arm trial with HC1 and 1 course of blinatumomab followed by allo-HSCT compared with historical controls",[18],{"label":24,"type":10,"description":25,"interventionNames":26},"Isolated extramedullary manifestations","single arm trial with the IntReALL SR 2010 Arm A (ALL-REZ BFM 2002) including blinatumomab replacing the chemotherapy element SCA3 compared with historical controls. SR patients will receive further conventional consolidation, local irradiation and maintenance, HR patients will be given allo-HSCT after blinatumomab",[18],[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Inotuzumab ozogamicin (INO)","Antibody Drug Conjugate (Inotuzumab)",[9],[34],"InO vs. R3 randomisation in SR",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Blinatumomab","Bispecific t-cell enganger BiTE",[20,24,15],[40],"Blinatumumab vs. historical control",[42],{"name":43,"affiliation":44,"role":45},"Arend Elisabeth von Stackelberg, Dr. med., MD","Charité - Universitätsmedizin","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Adriane E Napp, Dr. rer. medic, MSc","CONTACT","+17654426233",null,"adriane.napp@charite.de",[54,71,85,100,116,132,148,162,179,195,209,225,241,257,272,288,304,320,336,352],{"facility":55,"status":51,"city":56,"state":51,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"St. Anna Kinderspital GmbH","Vienna","1090","Austria","AT",{"type":61,"coordinates":62},"Point",[63,64],16.37208,48.20849,{"lat":64,"lon":63},[67],{"name":68,"role":49,"phone":69,"phoneExt":51,"email":70},"Andishe Attarbaschi, Dr. med., MD","+431401709117","andishe.attarbaschi@ccri.at",{"facility":72,"status":51,"city":73,"state":51,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Ghent University Hospital","Ghent","B-9000","Belgium","BE",{"type":61,"coordinates":78},[79,80],3.71667,51.05,{"lat":80,"lon":79},[83],{"name":84,"role":49,"phone":51,"phoneExt":51,"email":51},"Barbara De Moerloose, Dr. med., MD",{"facility":86,"status":51,"city":87,"state":51,"zip":88,"country":89,"countryCode":51,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Fakultni Nemocnice V Motole","Prague","150 00","Czechia",{"type":61,"coordinates":91},[92,93],14.42076,50.08804,{"lat":93,"lon":92},[96],{"name":97,"role":49,"phone":98,"phoneExt":51,"email":99},"Lucie Šrámková, Dr. med., MD","+420224436400","lucie.sramkova@fnmotol.cz",{"facility":101,"status":51,"city":102,"state":51,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Rigshospitalet","Copenhagen","2100","Denmark","DK",{"type":61,"coordinates":107},[108,109],12.56553,55.67594,{"lat":109,"lon":108},[112],{"name":113,"role":49,"phone":114,"phoneExt":51,"email":115},"Bodil Als-Nielsen, Dr. med., MD","+45 35451898","bodil.elise.thorhauge.als-nielsen@regionh.dk",{"facility":117,"status":51,"city":118,"state":51,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"HUS Helsinki University Hospital","Helsinki","FIN-00290","Finland","FI",{"type":61,"coordinates":123},[124,125],24.93545,60.16952,{"lat":125,"lon":124},[128],{"name":129,"role":49,"phone":130,"phoneExt":51,"email":131},"Samppa Ryhänen, Dr. med, MD","+358504270942","samppa.ryhanen@hus.fi",{"facility":133,"status":51,"city":134,"state":51,"zip":135,"country":136,"countryCode":137,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"CHU de NICE, Hôpital L'ARCHET","Nice","06202","France","FR",{"type":61,"coordinates":139},[140,141],7.26608,43.70313,{"lat":141,"lon":140},[144],{"name":145,"role":49,"phone":146,"phoneExt":51,"email":147},"Pierre Rohrlich, Dr. med., MD","+33492036377","rohrlich.ps@chu-nice.fr",{"facility":149,"status":51,"city":150,"state":51,"zip":51,"country":151,"countryCode":152,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Charité - Universitätsmedizin Berlin","Berlin","Germany","DE",{"type":61,"coordinates":154},[155,156],13.41053,52.52437,{"lat":156,"lon":155},[159],{"name":160,"role":49,"phone":161,"phoneExt":51,"email":52},"Arend E von Stackelberg, Dr. med., MD","+4930450666833",{"facility":163,"status":51,"city":164,"state":51,"zip":165,"country":166,"countryCode":167,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Semmelweis University","Budapest","1094","Hungary","HU",{"type":61,"coordinates":169},[170,171],19.04045,47.49835,{"lat":171,"lon":170},[174],{"name":175,"role":49,"phone":176,"phoneExt":177,"email":178},"Dániel Erdély, Dr. med., MD","+36 1 215 1380","52861","erdelyi.daniel@semmelweis.hu",{"facility":180,"status":51,"city":181,"state":51,"zip":182,"country":183,"countryCode":184,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Tel Aviv Sourasky Medical Centre Dana-Dwek Children's Hospital","Tel Aviv","64239","Israel","IL",{"type":61,"coordinates":186},[187,188],34.78057,32.08088,{"lat":188,"lon":187},[191],{"name":192,"role":49,"phone":193,"phoneExt":51,"email":194},"Ronit Elhasid, Dr. med., MD","+972-52-4266464","ronite@tlvmc.gov.il",{"facility":196,"status":51,"city":197,"state":51,"zip":198,"country":199,"countryCode":200,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Ospedale Pediatrico Bambino Gesu","Rome","00165","Italy","IT",{"type":61,"coordinates":202},[203,204],12.51133,41.89193,{"lat":204,"lon":203},[207],{"name":208,"role":49,"phone":51,"phoneExt":51,"email":51},"Franco Locatelli, Dr. med., MD",{"facility":210,"status":51,"city":211,"state":51,"zip":212,"country":213,"countryCode":214,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Prinses Máxima Centrum","Utrecht","3584 CS","Netherlands","NL",{"type":61,"coordinates":216},[217,218],5.12222,52.09083,{"lat":218,"lon":217},[221],{"name":222,"role":49,"phone":223,"phoneExt":51,"email":224},"Janine Stutterheim, Dr. med., MD","+31889727272","J.Stutterheim@prinsesmaximacentrum.nl",{"facility":226,"status":51,"city":227,"state":51,"zip":228,"country":229,"countryCode":230,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"University Wroclaw","Wroclaw","50 354","Poland","PL",{"type":61,"coordinates":232},[233,234],17.03006,51.10286,{"lat":234,"lon":233},[237],{"name":238,"role":49,"phone":239,"phoneExt":51,"email":240},"Monika Mielcarek, Dr. med., MD","+48 71 733 28 31","monika.mielcarek@umw.edu.pl",{"facility":242,"status":51,"city":243,"state":51,"zip":244,"country":245,"countryCode":246,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Instituto Português de Oncologia de Lisboa","Lisbon","1099-023","Portugal","PT",{"type":61,"coordinates":248},[249,250],-9.1498,38.72509,{"lat":250,"lon":249},[253],{"name":254,"role":49,"phone":255,"phoneExt":51,"email":256},"Joaquin Duarte, Dr. med., MD","+351 217229892","jduarte@ipolisboa.min-saude.pt",{"facility":258,"status":51,"city":259,"state":51,"zip":51,"country":260,"countryCode":261,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Fundeni Clinical Institute, Pediatric Clinic Fundeni","Bucharest","Romania","RO",{"type":61,"coordinates":263},[264,265],26.10626,44.43225,{"lat":265,"lon":264},[268],{"name":269,"role":49,"phone":270,"phoneExt":51,"email":271},"Anca Colita, Dr. med., MD","+40722207268","anca.colita@umfcd.ro",{"facility":273,"status":51,"city":274,"state":51,"zip":275,"country":276,"countryCode":277,"cosmosGeoPoint":278,"geoPoint":282,"contacts":283},"Univerzity Komenského a Národného","Bratislava","833 40","Slovakia","SK",{"type":61,"coordinates":279},[280,281],17.10674,48.14816,{"lat":281,"lon":280},[284],{"name":285,"role":49,"phone":286,"phoneExt":51,"email":287},"Alexandra Kolenová, Dr. med., MD","+421 (0)2 59371 230","alexandra.kolenova@nudch.eu",{"facility":289,"status":51,"city":290,"state":51,"zip":291,"country":292,"countryCode":293,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"University Medical Centre Ljubljana","Ljubljana","1000","Slovenia","SI",{"type":61,"coordinates":295},[296,297],14.50513,46.05108,{"lat":297,"lon":296},[300],{"name":301,"role":49,"phone":302,"phoneExt":51,"email":303},"Marko Kavčič, Dr. med., MD","+386 1 522 34 26","marko.kavcic@kclj.si",{"facility":305,"status":51,"city":306,"state":51,"zip":307,"country":308,"countryCode":309,"cosmosGeoPoint":310,"geoPoint":314,"contacts":315},"University Clinical Hospital Virgen De La Arrixaca","Murcia","30120","Spain","ES",{"type":61,"coordinates":311},[312,313],-1.13004,37.98704,{"lat":313,"lon":312},[316],{"name":317,"role":49,"phone":318,"phoneExt":51,"email":319},"José Luís Fuster Soler, Dr. med., MD","+34968369500","aaaaa@gmail.com",{"facility":321,"status":51,"city":322,"state":51,"zip":323,"country":324,"countryCode":325,"cosmosGeoPoint":326,"geoPoint":330,"contacts":331},"Karolinska University Hospital","Solna","171 64","Sweden","SE",{"type":61,"coordinates":327},[328,329],18.00086,59.36004,{"lat":329,"lon":328},[332],{"name":333,"role":49,"phone":334,"phoneExt":51,"email":335},"Petter Svenberg, Dr. med., MD","+46812380808","petter.svenberg@regionstockholm.se",{"facility":337,"status":51,"city":338,"state":51,"zip":339,"country":340,"countryCode":341,"cosmosGeoPoint":342,"geoPoint":346,"contacts":347},"University Children's Hospital","Zurich","8032","Switzerland","CH",{"type":61,"coordinates":343},[344,345],8.55,47.36667,{"lat":345,"lon":344},[348],{"name":349,"role":49,"phone":350,"phoneExt":51,"email":351},"Jean-Pierre Bourquin, Dr. med., MD","+41 44 249 57 16","jean-pierre.bourquin@kispi.uzh.ch",{"facility":353,"status":51,"city":354,"state":51,"zip":355,"country":356,"countryCode":51,"cosmosGeoPoint":357,"geoPoint":361,"contacts":362},"Acıbadem University","Istanbul","34752","Turkey (Türkiye)",{"type":61,"coordinates":358},[359,360],28.94966,41.01384,{"lat":360,"lon":359},[363],{"name":364,"role":49,"phone":365,"phoneExt":51,"email":366},"Koray Yalçın, Dr. med., MD","+905363236449","koray.yalcin@acibadem.com",{"type":45,"investigatorFullName":368,"investigatorTitle":369,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"PD Dr. Arend von Stackelberg","Prof. Dr. med","100629596","phase-3-international-study-for-treatment-of-childhood-relapsed-precursor-b-cell-all-2020-intreall-bcp-2020-100629596",false,"NCT07476729","International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)","International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group","Inclusion Criteria:\n\nFor all study questions:\n\n* Confirmed diagnosis of 1st relapsed B-cell precursor ALL\n* Patients ≥ 1 year and less than 18 years of age at diagnosis of primary ALL and less than 21 years of age at date of inclusion into the study\n* Patient enrolled in a participating center\n* Written informed consent (IC)\n* Start of treatment falling into the study period\n* No participation in other clinical trials 30 days prior to study enrolment that interfere with this protocol, except trials for primary ALL\n\nSpecific for SR induction randomization:\n\n* Meeting SR criteria\n* BM involvement (≥ 5% or ≥ 1% leukemic blasts confirmed by 2 quantitative methods)\n* CD22 positive ALL (\\>80% confirmed by flow-cytometry)\n* No previous history of veno-occlusive disease (VOD)\u002F sinusoidal obstruction syndrome (SOS)\n\nSpecific for SR MRD poor response consolidation:\n\n* Meeting SR criteria with bone marrow involvement at relapse diagnosis\n* M1\u002FCR2 and MRD ≥ 10-4 after induction\n* CD19 positive ALL at relapse (\\>10%)\n\nSpecific for SR MRD good response consolidation:\n\n* Meeting SR criteria with bone marrow involvement at relapse diagnosis\n* M1\u002FCR2 and MRD \\\u003C 10-4 after induction\n* CD19 positive ALL at relapse (\\>10%) Specific for HR consolidation arm\n* Meeting HR or VHR (in case of no possibility to be treated with CAR T cells) criteria\n* M1\u002FCR2 after induction therapy\n* CD19 positive ALL at relapse (\\>10%)\n\nSpecific for IEM arm:\n\n* Histology or cytology proven extramedullary relapse\n* No bone marrow involvement (M1 at relapse diagnosis) and bone marrow MRD \\\u003C1%\n* CD19 positive ALL at relapse (\\>10%)\n\nExclusion Criteria:\n\n* Known hypersensitivity to the active substances or excipients of the IMP's or the SOC drugs, except to PEG-asparaginase which can be replaced by Erwinase\n* Left ventricular ejection fraction (LVEF) \\\u003C 50% or fractional shortening \\\u003C 25%, and\u002For current or prior treatment for cardiomyopathy and\u002For history of clinically significant arrhythmias\n* Pregnancy or positive pregnancy test in female patients (urine sample positive for β-HCG \\> 10 U\u002Fl) at screening or within 7 days prior to the initiation of study treatment\n* Sexually active adolescents and adults not willing to use highly effective contraceptive method (pearl index \\\u003C1) until 12 months after end of anti-leukemic therapy\n* Women not willing to refrain from breast feeding until 12 months after end of anti-leukemic therapy\n* Relapse post allogeneic HSCT\n* Relapse post chimeric antigen receptor T-cell (CAR-T) therapy\n* The whole protocol or essential parts are declined either by patient himself\u002Fherself or the respective legal guardian\n* Objection to the study participation by a minor patient\n* Patients in a dependent or subordinate relationship to the investigator or site staff (e.g. employees, relatives, or students)\n* No consent is given for saving and propagation of pseudonymized medical data for study reasons\n* Patients with any concurrent medical condition, laboratory abnormality, concomitant treatment, or comorbidity that, in the investigator's clinical judgment would\n\n  * compromise the patient's ability to safely receive or tolerate inotuzumab ozogamicin and\u002For blinatumomab\n  * significantly interfere with assessment of treatment efficacy or safety\n  * make it unlikely that the patient would derive clinical benefit from protocol therapy\n  * preclude adherence to study procedures or follow-up requirements\n* Subjects unwilling or unable to comply with the study procedures\n* Subjects who are legally detained in an official institute\n\nSpecific for SR induction randomization:\n\n* Prior confirmed severe (grade 3 or 4) or ongoing VOD\u002FSOS\n* Serious ongoing hepatic disease (e.g., cirrhosis, active hepatitis) not related to the current ALL relapse or current diagnostic\u002Ftherapeutic measures\n* ALT \\> 2,5 x ULN (at relapse diagnosis before start of cytoreduction) and\u002For bilirubin \\> 1.5 x ULN\n* Patients with intolerance to PEG-asparagniase and also to Erwinase are stratified to the inotuzumab arm\n* Patients with insufficient expression of CD22 (\\\u003C 80%) on leukemic blasts, they are assigned to the control chemotherapy arrm\n\nSpecific for blinatumomab treatment:\n\n* Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy)\n* Evidence of current CNS (CNS 2, CNS 3) involvement by ALL. Subjects with CNS relapse at the time of relapse are eligible if CNS is successfully treated prior to enrollment\n\nAllowed systemic diseases and concomitant medication\n\n* Patients with Down Syndrome (DS) can be included as separate and descriptive population, not joining the study questions. Those with BM involvement receive inotuzumab ozogamicin for induction without randomization. HR patients and SR patients with MRD poor response will be allocated to allo-HSCT indication, or in case CD19 directed CAR-T-cell therapy off-protocol as individualized treatment approach. Patients with MRD good response will get the SR consolidation and maintenance therapy. Those with IEM profile will be treated according to the IEM stratum. Patients not expressing sufficiently CD22 and\u002For CD19 will receive the respective chemotherapy strategy.\n* Patients with BCR::ABL positive (Ph+) or BCR::ABL like (Ph-like) BCP ALL with TKI treatment option can be included as separate and descriptive population, not joining the study questions. Those with BM involvement receive inotuzumab ozogamicin plus TKI (investigators choice) without randomization for induction followed by HC1 and blinatumomab plus TKI followed by allo-HSCT. Those with IEM profile will be treated according to the IEM stratum plus TKI. Patients not expressing sufficiently CD22 and\u002For CD19 will receive the respective chemotherapy strategy.\n* Patients with systemic diseases such as cystic fibrosis or diabetes may be eligible for enrolment in this study only if they presumably will tolerate the protocol treatment and primary dose reductions would not be necessary.\n* Any kind of concomitant medication given due to medical reasons is allowed. Incompatibilities and drug interactions with the study medications are listed in the appendix. In case of expected adverse interactions, concomitant therapies should be changed to alternative less problematic agents if possible\n\nProhibited medication\n\n* Antileukemic therapy other than scheduled in the protocol (except cytoreductive pre-phase with dexamethasone)\n* Investigational drugs other than scheduled in the protocol\n* Attenuated live vaccines which are strictly prohibited during and until 6 months after end of chemotherapy or 18 months after allo-HSCT","ALL","1 Year",{"count":380,"type":381},750,"ESTIMATED","INTERVENTIONAL",[384],"PHASE3","The IntReALL BCP 2020 study aims to review recent developments and findings regarding chemoimmunotherapy with inotuzumab and immunotherapy with blinatumomab and to increase the use of promising new immunotherapeutic drugs as replacements for toxic SOC chemotherapy elements.\n\nThe IntReALL BCP 2020 study has the potential to improve CR and EFS rates for all SR and HR groups, as well as for patients with IEM recurrence, by replacing toxic chemotherapy with targeted, less toxic immunotherapy strategies, and could establish these new approaches as SOC for children with relapsed BCP ALL in the future.",[387],"B-Cell Acute Lymphoblastic Leukaemia",[389],"Lymphoblastic","NOT_YET_RECRUITING","2026-03-12",{"date":393,"type":394},"2026-03-17","ACTUAL",{"date":396,"type":381},"2026-04-01",{"date":398,"type":381},"2033-03-31",{"name":5,"class":6},20]