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Palmar","Murcia","30120",{"type":51,"coordinates":664},[665,666],-1.16095,37.93939,{"lat":666,"lon":665},{"facility":669,"status":45,"city":650,"state":40,"zip":670,"country":622,"countryCode":623,"cosmosGeoPoint":671,"geoPoint":673,"contacts":40},"Hospital Universitario La Paz","28046",{"type":51,"coordinates":672},[655,656],{"lat":656,"lon":655},{"facility":618,"status":45,"city":619,"state":40,"zip":621,"country":622,"countryCode":623,"cosmosGeoPoint":675,"geoPoint":677,"contacts":40},{"type":51,"coordinates":676},[626,627],{"lat":627,"lon":626},{"facility":679,"status":45,"city":680,"state":40,"zip":681,"country":622,"countryCode":623,"cosmosGeoPoint":682,"geoPoint":686,"contacts":40},"Hospital Universitario Virgen Del Rocio","Seville","41013",{"type":51,"coordinates":683},[684,685],-5.97317,37.38283,{"lat":685,"lon":684},{"facility":688,"status":45,"city":689,"state":40,"zip":690,"country":622,"countryCode":623,"cosmosGeoPoint":691,"geoPoint":695,"contacts":40},"Hospital Universitari i Politecnic La Fe","Valencia","46026",{"type":51,"coordinates":692},[693,694],-0.37966,39.47391,{"lat":694,"lon":693},{"facility":697,"status":45,"city":698,"state":699,"zip":700,"country":701,"countryCode":702,"cosmosGeoPoint":703,"geoPoint":707,"contacts":40},"Skånes Universitetssjukhus Lund","Lund","Skåne LÄN [se-12]","22185","Sweden","SE",{"type":51,"coordinates":704},[705,706],13.19321,55.70584,{"lat":706,"lon":705},{"facility":709,"status":45,"city":710,"state":711,"zip":712,"country":701,"countryCode":702,"cosmosGeoPoint":713,"geoPoint":717,"contacts":40},"Sahlgrenska Universitetssjukhuset Östra","Gothenburg","Västra Götalands LÄN [se-14]","416 85",{"type":51,"coordinates":714},[715,716],11.96679,57.70716,{"lat":716,"lon":715},{"facility":719,"status":45,"city":720,"state":40,"zip":721,"country":701,"countryCode":702,"cosmosGeoPoint":722,"geoPoint":726,"contacts":40},"Astrid Lindgrens Barnsjukhus","Stockholm","17067",{"type":51,"coordinates":723},[724,725],18.06871,59.32938,{"lat":725,"lon":724},{"facility":728,"status":45,"city":729,"state":730,"zip":731,"country":732,"countryCode":733,"cosmosGeoPoint":734,"geoPoint":738,"contacts":40},"Inselspital Bern","Bern","Canton of Bern","3010","Switzerland","CH",{"type":51,"coordinates":735},[736,737],7.44744,46.94809,{"lat":737,"lon":736},{"facility":740,"status":45,"city":741,"state":742,"zip":743,"country":732,"countryCode":733,"cosmosGeoPoint":744,"geoPoint":748,"contacts":40},"CHUV (centre hospitalier universitaire vaudois)","Lausanne","Canton of Vaud","1011",{"type":51,"coordinates":745},[746,747],6.63282,46.516,{"lat":747,"lon":746},{"facility":750,"status":45,"city":751,"state":40,"zip":752,"country":732,"countryCode":733,"cosmosGeoPoint":753,"geoPoint":757,"contacts":40},"Kinderspital Zürich","Zurich","8008",{"type":51,"coordinates":754},[755,756],8.55,47.36667,{"lat":756,"lon":755},{"type":759,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100496740","phase-2-a-study-to-learn-more-about-the-study-medicine-called-inotuzumab-ozogamicin-ino-in-children-1-to-18-years-with-first-relapse-all-100496740",false,"NCT05748171","A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to \u003C18 Years) With First Relapse ALL","A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH-RISK OR VERY HIGH-RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA","Inclusion Criteria:\n\n1. Male or female participants between 1 and \\\u003C18 years of age.\n2. Morphologically confirmed diagnosis of first relapse HR or VHR BCP ALL; HR first relapse is defined as relapse occurring within 18 to 30 months of original diagnosis of ALL or within 6 months of completion of primary therapy, and lacking any identified very high-risk genetic abnormalities (Groeneveld-Krentz et al, 2019) (ie, KMT2A::AFF1 fusion \\[t(4;11)(q21;q23)\\], TCF3-HLF fusion \\[t(17;19)(q22;p13)\\], TCF3-PBX1 fusion \\[t(1;19)(q23;p13.3)\\], hypodiploidy \\[\\\u003C40 chromosomes\\] or masked low hypodiploidy (Molina et al, 2021), TP53 alteration). VHR first relapse is defined as relapse within 18 months of original diagnosis of ALL and\u002For with any of the following genetic abnormalities at original diagnosis or at relapse (Groeneveld-Krentz et al, 2019) (ie, KMT2A::AFF1 fusion \\[t(4;11)(q21;q23)\\], TCF3-HLF fusion \\[t(17;19)(q22;p13)\\], TCF3-PBX1 fusion \\[t(1;19)(q23;p13.3)\\], hypodiploidy \\[\\\u003C40 chromosomes\\] or masked low hypodiploidy (Molina et al, 2021), TP53 alteration).\n\n   * CD22-positive ALL as defined by local institution;\n   * Bone marrow involvement of ≥ 5% leukemic blasts (≥ M2 status).\n3. Adequate serum chemistry parameters:\n\n   * An eGFR in participants 1 to \\\u003C2 years of age, or eCrCl in those 2 to \\\u003C18 years of age, ≥30 mL\u002Fmin using the recommended formula in Section 10.10.2.\n   * AST and ALT ≤5 × institutional ULN at the time of randomization or pre-cytoreduction\u002Fgeneral anesthesia; (Refer to Appendix 9 for France-specific requirement on the ALT\u002FAST threshold);\n   * Total bilirubin ≤1.5 × institutional ULN unless the participant has documented Gilbert's syndrome;\n4. Prior history of thrombosis during corticosteroid use and\u002For asparaginase are eligible provided the patient receives anti-coagulant prophylaxis per institutional guidelines.\n5. Cardiac shortening fraction ≥ 30% by echocardiogram or ejection fraction \\>50% by MUGA.\n\n6 Participants with combined bone marrow and testicular relapse are eligible assuming orchiectomy is performed prior to randomization or is planned at the end of induction therapy.\n\n5.2. Exclusion Criteria\n\n1. Any history of prior or ongoing hepatic SOS or prior liver failure \\[defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of ≥1.5)\\].\n2. Prior allo-HSCT or CAR T-cell therapy.\n3. Isolated extramedullary leukemia.\n4. Philadelphia-chromosome positive ALL, ie. BCR-ABL\u002Ft(9;22) present.\n5. Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin).\n6. Participants with active, uncontrolled bacterial, fungal, or viral infection.\n7. Hypersensitivity\u002Fallergy to both PEG-ASP and Erwinia-ASP","ALL","1 Year","17 Years",{"count":771,"type":772},100,"ESTIMATED","INTERVENTIONAL",[775],"PHASE2","This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and \\\u003C18 years) with High Risk (HR) or very high risk (VHR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization.",[778],"ACUTE LYMPHOBLASTIC LEUKEMIA",[767,780,781,782,783,784],"BCP ALL","High risk BCP ALL","Relapse ALL","Leukemia","Very high risk BCP ALL","2026-06-10",{"date":787,"type":788},"2026-06-11","ACTUAL",{"date":790,"type":788},"2023-05-17",{"date":792,"type":772},"2036-11-04",{"name":5,"class":6},74]