[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"St. Anna Kinderkrebsforschung\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100205295","phase-2-allogeneic-stem-cell-transplantation-for-children-and-adolescents-with-acute-lymphoblastic-leukaemia-100205295",false,"NCT01949129","Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia","Inclusion Criteria:\n\nPatients with ALL (except for patients with B-ALL) who fulfil the following criteria:\n\n* age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years\n* indication for allogeneic HSCT\n* complete remission (CR) before HSCT\n* written consent of the parents (legal guardian) and, if necessary, the minor patient via \"Informed Consent Form\"\n* no pregnancy\n* no secondary malignancy\n* no previous HSCT\n* HSCT is performed in a study participating centre\n\nExclusion Criteria:\n\n* patients who do not fulfil the inclusion criteria\n* Non Hodgkin-Lymphoma\n* the whole protocol or essential parts are declined either by patient himself\u002Fherself or the respective legal guardian\n* no consent is given for saving and propagation of anonymous medical data for study reasons\n* severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)\n* Karnofsky \u002F Lansky score \\\u003C 50%\n* subjects unwilling or unable to comply with the study procedures","ALL","1 Month","18 Years",{"count":19,"type":20},1800,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen.\n\nThe stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.",[27],"Acute Lymphoblastic Leukaemia",[29,30,31],"stem cell transplantation","children and adolescents","high risk acute lymphoblastic leukaemia","RECRUITING","2024-01-12",{"date":35,"type":36},"2024-01-16","ACTUAL",{"date":38,"type":4},"2013-04",{"date":40,"type":20},"2030-04",{"name":42,"class":43},"St. Anna Kinderkrebsforschung","OTHER",119,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100186609","phase-3-high-risk-neuroblastoma-study-18-of-siop-europe-siopen-100186609","NCT01704716","High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)","High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN)","Inclusion Criteria:\n\n* • Established diagnosis of neuroblastoma according to the International Neuroblastoma Staging System (INSS).\n\n  * Age below 21 years.\n  * High risk neuroblastoma defined as either:\n\n    1. INSS stage 2, 3, 4, and 4s with MYCN amplification, or\n    2. INSS stage 4 without MYCN amplification aged \\> 12 months at diagnosis\n  * Patients who have received no previous chemotherapy except for one cycle of etoposide and carboplatin (VP16\u002FCarbo). In this situation patients will receive Rapid COJEC induction and the first Rapid COJEC cycle may be replaced by the first cycle VP16\u002FCarbo (etoposide \u002F carboplatin).\n  * Written informed consent, including agreement of parents or legal guardian for minors, to enter a randomised study if the criteria for randomisation are met.\n  * Tumour cell material available for determination of biological prognostic factors.\n  * Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method. Female patients who are lactating must agree to stop breast-feeding.\n  * Registration of all eligibility criteria with the data centre within 6 weeks from diagnosis.\n  * Provisional follow up of 5 years.\n  * National and local ethical committee approval.\n\nExclusion Criteria:\n\nAny negative answer concerning the inclusion criteria of the study\n\n\\-","21 Years",{"count":54,"type":20},3300,[24],"This is a randomized study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified \\> 12 months at diagnosis).\n\nThe protocol consists of a rapid, dose intensive induction chemotherapy, peripheral blood stem cell harvest, attempted complete excision of the primary tumour, myeloablative therapy followed by peripheral blood stem cell rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomization - isotretinoin and ch14.18\u002FCHO (Dinutuximab beta, Qarziba ®).), with or without s.c. aldesleukin (IL-2)). Patients diagnosed after the closure of R3 randomization will not be R4 randomized. For these patients the use of ch14.18\u002FCHO antibody is recommended without scIL-2 as continuous infusion as standard of care outside of controlled trials. ch14.18\u002FCHO received marketing authorization by EMA in May 2017 (Qarziba ®).\n\nIn the induction phase, all patients receive Rapid COJEC following the result of the R3 randomization which was closed on June 8th, 2017 after inclusion of 630 patients as planned.\n\nFollowing induction treatment peripheral blood stem cell harvest (PBSCH) is performed and complete excision of the primary tumour will be attempted.\n\nPatients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles.\n\nAfter Rapid COJEC induction, localized patients will proceed to consolidation. Patients aged 12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without segmental chromosomal alterations (SCAs) are thought to have a good prognosis and will stop treatment after induction therapy and surgery to the primary tumour.\n\nConsolidation consists of BuMel MAT based on the results of the R1 randomization followed by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary tumour.\n\nThe R2 immunotherapy randomization using ch14.18\u002FCHO as 8 hour infusion on 5 consecutive days ( total dose (100mg\u002Fm²) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) is closed.\n\nThe amended R4 immunotherapy randomization using ch14.18\u002FCHO as continuous infusion (total dose 100mg\u002Fm² over 10 days) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) has accrued according to plan with results pending awaiting data maturity and DMC approval.",[58],"Neuroblastoma",[60,61,62,63],"neuroblastoma","immunotherapy","MAT","antibody treatment","2020-10-21",{"date":66,"type":36},"2020-10-23",{"date":68,"type":4},"2002-02",{"date":70,"type":20},"2026-09",{"name":42,"class":43},126,""]