[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460188":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":51,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Jagiellonian University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention arm","EXPERIMENTAL","Chemoimmunotherapy arm.",[13],"Combination Product: Chemoimmunotherapy (Dinutuximab beta in combination with chemotherapy)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","Chemoimmunotherapy (Dinutuximab beta in combination with chemotherapy)","Dinutuximab beta in combination with chemotherapy.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Walentyna Balwierz, Prof.","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+48 12 333 92 20","walentyna.balwierz@uj.edu.pl",{"name":31,"role":27,"phone":28,"phoneExt":20,"email":32},"Aleksandra Wieczorek, Dr","a.wieczorek@uj.edu.pl",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University Children Hospital","RECRUITING","Krakow","Malopolska","30-663","Poland","PL",{"type":43,"coordinates":44},"Point",[45,46],19.93658,50.06143,{"lat":46,"lon":45},[49],{"name":23,"role":27,"phone":50,"phoneExt":20,"email":29},"+48123339220",{"type":24,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Walentyna Balwierz","Prof.","100460188","phase-1-immunotherapy-with-dinutuximab-beta-in-combination-with-chemotherapy-for-the-treatment-of-patients-with-primary-neuroblastoma-refractory-to-standard-therapy-and-with-relapsed-or-progressive-disease-100460188",false,"NCT05272371","Immunotherapy With Dinutuximab Beta in Combination With Chemotherapy for the Treatment of Patients With Primary Neuroblastoma Refractory to Standard Therapy and With Relapsed or Progressive Disease","ChIm-NB-PL","Inclusion Criteria:\n\n1. Diagnosis of NBL according to international criteria (International Neuroblastoma Risk Group, INRG).\n2. Patients 1-18 years of age with HR-NBL with primary refractory disease, disease progression or recurrence.\n3. Adequate function of vital organs (if abnormal, dysfunction below grade 4 according to the CTC AE WHO classification, except for disorders defined in the exclusion criteria).\n4. Life expectancy ≥6 months.\n5. Obtaining the informed written consent of the patient and\u002For statutory representative for the treatment.\n6. Female patients of childbearing potential must consent to the use of effective contraception; Breastfeeding patients must consent to the termination of breastfeeding.\n7. Patients who have previously received immunotherapy with DB or other anti-GD2 specific antibodies may be eligible for this study.\n\nExclusion Criteria:\n\n1. Patients with toxicities of ≥3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders.\n2. Patients with neurological toxicities of ≥2 CTCAE WHO grade.\n3. Active life-threatening infection until stabilization of the patient's condition.\n4. Pregnancy and \u002F or lactation.\n5. Sexually active patients who refuse to use an effective method of contraception.\n6. Current treatment with experimental drugs or use of such treatment within 2 weeks before signing the informed consent to participate in the study.\n7. Radiotherapy within 3 weeks prior to the start of the study.\n8. Participation in another clinical trial within 6 months before signing the informed consent to participate in the trial (not applicable to clinical trials in 1st line of treatment in HR-NBL).\n9. Lack of informed written consent to treatment.","ALL","1 Year","18 Years",{"count":65,"type":66},20,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","Safety evaluation and initial efficacy evaluation will be conducted in a group of patients as a non-commercial, open-label clinical trial of dinutuximab beta (Qarziba) phase IIa.\n\nThe investigational medicinal product will be dinutuximab beta (anti-GD2 antibodies against GD2 disialoganglioside on NBL cells) at a dose of 10 mg \u002F m2 \u002F day by continuous infusion for 5 days in combination with irinotecan \u002F temozolomide, topotecan \u002F temozolomide or N5 \u002F N6 chemotherapy GPOH protocol.\n\nThe study group will be patients with recurrent \u002F progression of NBL or disease resistant to first-line treatment, for whom there are currently no standards of management, and the treatment methods used so far do not give a chance to achieve a permanent remission of the disease. After diagnosis of relapse \u002F progression or resistance to treatment, it is permissible to administer 2 cycles of standard chemotherapy prior to enrollment in the study.\n\nThe study plans to recruit 20 patients who will receive 5-7 cycles of DB with chemotherapy. The choice of an appropriate chemotherapy regimen will depend on the patient's prior treatment and tolerance.\n\nThe safety assessment will be conducted based on the registration of the types and frequency of adverse reactions identified on the basis of the registration of clinical parameters, symptoms and \u002F or diseases reported by the patient or identified during the intervention and \u002F or follow-up visits, abnormal laboratory and \u002F or imaging test results.\n\nThe initial assessment of the effectiveness will consist in comparing the percentage of objective responses obtained and the annual EFS and PFS (imaging tests, including scintigraphy, bone marrow examination and tumor markers). The study also included an exploratory evaluation of the usefulness of immunological, genetic and other studies.",[72],"High-Risk Neuroblastoma",[74],"neuroblastoma dinutuksymab beta chemoimmunotherapy","2022-03-08",{"date":77,"type":78},"2022-03-09","ACTUAL",{"date":80,"type":78},"2021-12-01",{"date":82,"type":66},"2026-12-31",{"name":5,"class":6},1]