[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Anna Raciborska\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":114},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,67,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100434902","phase-2-optimization-of-the-time-and-dosage-of-trametinib-in-braf-negative-juvenile-patients-100434902",false,"NCT04943224","Optimization of the Time and Dosage of Trametinib in BRAF Negative Juvenile Patients","Optimization of the Time and Dosage of Trametinib in BRAF Negative Juvenile Patients With Refractory Histiocytosis or After the Failure of Vemurafenib Treatment","TRAM","Inclusion Criteria:\n\n1. Lack of mutations in the BRAF gene in tumor tissues and\u002For circulating tumor DNA (ctDNA) at any stage of treatment or follow-up, or failure of Vemurafenib treatment in BRAF positive patients.\n2. Failure of the treatment (at least one of below needs to apply in order for this requirement to be satisfied):\n\n   1. Progression on the I and\u002For II line treatment, including at least one risk organ; prior treatment should include a minimum of 6 weeks of weekly Vinblastine with a minimum of 28 days prednisolone or minimum 2 cycles of Cytosine Arabinoside in 4-day cycles and\u002For Cladribine in 5-day cycles as a 2nd line treatment, minimum 2 cycles, or other second-line treatment or\n   2. Disease reactivation after an initial response to treatment with Vimblastine and prednisolone as the first line and\u002For no response to second line treatment using one of two drugs: Cytosine Arabinoside in 4- day cycles and\u002For Cladribine in 5-day cycles, minimum 2 cycles, or other I\u002F II line treatment or occurrence of involvement of at least one risk organ or\n\n   d. Progression during Vemurafenib therapy, or e. Reactivation of disease after Vemurafenib therapy has been completed, or f. The appearance of signs of neurodegenerative disorder (ND) in MRI of the central nervous system (CNS).\n3. Signing of informed consent for trial participation (including for Trametinib treatment) according with current legal regulations.\n4. Consent to the use of effective contraception throughout the Trametinib administration period and a minimum of 1 year after discontinuation in patients at puberty and sexual maturity.\n5. Participation in HISTIOGEN trial.\n\nExclusion Criteria:\n\n1. Lack of inclusion criteria.\n2. Pregnancy and breastfeeding .\n3. Hypersensitivity to the study drug or any of its ingredients.\n4. Iritis, uveitis, obstruction of the retinal veins.\n5. Simultaneous treatment with other drugs which might interact with Trametinib.\n6. Persistent toxicity related to prior therapy, making it impossible to treat with Trametinib.\n7. Diagnosis of other malignancies before study inclusion.\n8. Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the trial.","ALL","1 Year","18 Years",{"count":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Prospective, interventional, open, randomized, single-center, non-commercial clinical trial to optimize treatment and dosage of trametinib in juvenile patients with histiocytosis resistant to conventional therapy and without the BRAF gene mutation or after the failure of vemurafenib treatment.",[28],"Histiocytosis",[30,31,32,33],"Langerhans cell histiocytosis (LCH)","histiocytosis","trametinib","paediatric patients","RECRUITING","2026-03-24",{"date":37,"type":38},"2026-03-27","ACTUAL",{"date":40,"type":38},"2021-04-01",{"date":42,"type":22},"2027-06-30",{"name":44,"class":45},"Anna Raciborska","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":66,"locationsCount":46},"100434900","phase-2-optimization-of-the-time-and-dosage-of-vemurafenib-in-braf-positive-juvenile-patients-with-refractory-histiocytosis-100434900","NCT04943198","Optimization of the Time and Dosage of Vemurafenib in BRAF Positive Juvenile Patients With Refractory Histiocytosis","BRAVO","Inclusion Criteria:\n\n1. The presence of mutations in the BRAF gene in tumor tissues and\u002For in circulating tumor DNA (ctDNA) at any stage of treatment or follow-up.\n2. Failure of the treatment (at least one of below needs to apply in order for this requirement to be satisfied):\n\n   1. Progression on the I and\u002For II line treatment, including at least one risk organ; prior treatment should include a minimum of 6 weeks of weekly Vinblastine with a minimum of 28 days prednisolone or minimum 2 cycles of Cytosine Arabinoside in 4-day cycles and\u002For Cladribine in 5-day cycles as a 2nd line treatment, minimum 2 cycles, or other second-line treatment or\n   2. Disease reactivation after an initial response to treatment with Vimblastine and prednisolone as the first line and\u002For no response to second line treatment using one of two drugs: Cytosine Arabinoside in 4-day cycles and\u002For Cladribine in 5-day cycles, minimum 2 cycles, or other I\u002F II line treatment or occurrence of involvement of at least one risk organ or\n   3. Third or subsequent reactivation of disease with or without risk organ involvement, or\n   4. Reactivation of disease after Vemurafenib therapy has been completed, or\n   5. The appearance of signs of neurodegenerative disorder (ND) in MRI of the central nervous system (CNS).\n3. Signing of informed consent for trial participation (including for Vemurafenib treatment) according with current legal regulations.\n4. Consent to the use of effective contraception throughout the Vemurafenib administration period and a minimum of 1 year after discontinuation in patients at puberty and sexual maturity.\n5. Participation in HISTIOGEN trial.\n\nExclusion Criteria:\n\n1. Lack of inclusion criteria.\n2. Pregnancy and breastfeeding .\n3. Hypersensitivity to the study drug or any of its ingredients.\n4. Iritis, uveitis, obstruction of the retinal veins.\n5. Simultaneous treatment with other drugs which might interact with Vemurafenib.\n6. Persistent toxicity related to prior therapy, making it impossible to treat with Vemurafenib.\n7. Diagnosis of other malignancies before study inclusion.\n8. Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the trial.",{"count":55,"type":22},25,[25],"Prospective, interventional, open, randomized, single-center, non-commercial clinical trial to optimize treatment and dosage of vemurafenib in juvenile patients with histiocytosis resistant to conventional therapy and in whom the BRAF gene mutation has been found.",[28],[30,60,61,62,33],"vemurafenib","children","refractory histiocytosis",{"date":37,"type":38},{"date":40,"type":38},{"date":42,"type":22},{"name":44,"class":45},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":88,"locationsCount":46},"100434901","phase-3-determination-of-molecular-status-the-efficacy-and-safety-of-fluorodeoxyglucose-in-pet-ct-imaging-100434901","NCT04943211","Determination of Molecular Status, the Efficacy and Safety of Fluorodeoxyglucose in PET-CT Imaging","Determination of Molecular Status, as Well as the Efficacy and Safety of Fluorodeoxyglucose (18F-FDG) in PET-CT Imaging in Juvenile Patients With Histiocytosis","HISTIOGEN","Inclusion Criteria:\n\n1. Patient under 18 years of age at the time of inclusion.\n2. Histopathologically confirmed or suspected histiocytosis (based on prior test results).\n3. Signing of informed consent for trial participation according with current legal regulations.\n\nExclusion Criteria:\n\n1. Lack of inclusion criteria.\n2. Pregnancy.\n3. Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the trial.",{"count":76,"type":22},150,[78],"PHASE3","Prospective, low intervention, open, single-center, non-commercial clinical trial to improve diagnostics in patients with histiocytosis by assessing the molecular profile of the tumor tissues, monitoring its presence in free-circulating DNA, and determining the efficacy of fluorodeoxyglucose (18F-FDG) in PET-CT imaging.",[28],[30,31,82,83,33],"Positron Emission Tomography (PET)","molecular status",{"date":85,"type":38},"2026-03-25",{"date":40,"type":38},{"date":42,"type":22},{"name":44,"class":45},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100513691","phase-2-to-evaluate-the-efficacy-and-safety-of-naxitamab-in-patients-with-refractory-ewings-sarcoma-butterfly-100513691","NCT05968768","To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma (Butterfly)","To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma","Inclusion Criteria:\n\n1. Histologically proven Ewing sarcoma of the bone or soft tissues.\n2. Subject's archival tumour sample (formalin-fixed, paraffin-embedded; FFPE) available for evaluation of GD2 expression.\n3. Documented disease progression (during or after completion of at least one line treatment) or any subsequent recurrence.\n4. GD2 positive tumor assessed by IHC.\n5. Age ≥ 2 years and ≤ 21 years.\n6. Life expectancy of at least 12 weeks from the time informed consent was signed.\n7. Previous systemic anticancer treatment completed ≥ 3 weeks, major surgery ≥ 2 weeks, and radiation therapy ≥ 4 weeks prior to study enrollment.\n8. Recovered from adverse effects of prior surgery, radiotherapy, or Clinical trial protocol BUTTERFLY version 1.0 of 30.09.2022 r.anti-neoplastic therapy at the discretion of the investigator.\n9. Signing of informed consent for trial participation (including for naxitamab treatment) according with current legal regulations.\n10. Consent to the use of effective contraception throughout the period of the study and a minimum of 1 year after discontinuation of study treatment in patients at puberty and sexual maturity\n\nExclusion Criteria:\n\n1. Failure to meet any of the inclusion criteria.\n2. Not eligible to IT.\n3. Previous treatment with an anti-GD2 antibody.\n4. Hypersensitivity to the study drugs or any of their ingredients (covers IT and naxitamab).\n5. Simultaneous treatment with other drugs which might interact with naxitamab or IT regimen.\n6. Persistent toxicity related to prior therapy, making it impossible to treat with naxitamab.\n7. Significant cardiac conduction abnormalities, including known familial prolonged QT syndrome, or screening corrected QT interval (QTc) \\>480 msec.\n8. Symptoms of congestive heart failure or left ventricular ejection fraction \\\u003C50%.\n9. Inadequate pulmonary function defined as evidence of dyspnea at rest, exercise intolerance, and\u002For chronic oxygen requirement. In addition, room air pulse oximetry \\\u003C 94% and\u002For abnormal pulmonary function tests if these assessments are clinically indicated.\n10. Requirement, or likely requirement, for corticosteroids at doses \\>10 mg prednisolone (or equivalent) per day or other immunosuppressive agents.\n11. Diagnosis of other malignancies before study inclusion.\n12. Planning to become pregnant (while being treated with IT or naxitamab), pregnancy or breastfeeding.\n13. Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the tri","2 Years","21 Years",{"count":99,"type":22},24,[25],"Prospective, interventional, open, randomized, national, multicenter, non-commercial trial",[103],"Ewing Sarcoma",[103],"2025-04-09",{"date":107,"type":38},"2025-04-10",{"date":109,"type":38},"2023-10-24",{"date":111,"type":22},"2028-07-31",{"name":44,"class":45},2,""]