[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434902":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":55,"collaborators":58,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":36,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":40,"whyStopped":36,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Institute of Mother and Child, Warsaw, Poland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"R1 time of trametinib treatment","EXPERIMENTAL","Patients with negative status of any mutation in ctDNA or 0-1 Disease Activity Score (DAS) in three consecutive tests in three month intervals.",[13],"Drug: Trametinib",{"label":15,"type":10,"description":16,"interventionNames":17},"R2 time of trametinib treatment","Patients with negative status of any mutation in ctDNA or 0-1 Disease Activity Score (DAS) in in five consecutive tests in three month intervals.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Trametinib","\\\u003C 6 lat 0,032mg\u002Fkg, ≥ 6 lat 0,025mg\u002Fkg,",[9,15],[25],"Mekinist",[27],{"name":28,"affiliation":29,"role":30},"Anna Raciborska","Mother and Child Institute","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Katarzyna Maleszewska","CONTACT","+48 22 32 77 205",null,"klinika.onkologii@imid.med.pl",[39],{"facility":29,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Warsaw","Mazovian","01-211","Poland","PL",{"type":47,"coordinates":48},"Point",[49,50],21.01178,52.22977,{"lat":50,"lon":49},[53,54],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},{"name":28,"role":30,"phone":36,"phoneExt":36,"email":36},{"type":56,"investigatorFullName":28,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"SPONSOR_INVESTIGATOR","Prof Ass",[59,61,64],{"name":60,"class":6},"Maria Sklodowska-Curie National Research Institute of Oncology",{"name":62,"class":63},"Łukasiewicz Research Network","UNKNOWN",{"name":65,"class":6},"Wroclaw University of Environmental and Life Sciences","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":78,"type":79},12,"ESTIMATED","INTERVENTIONAL",[82],"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.",[85],"Histiocytosis",[87,88,89,90],"Langerhans cell histiocytosis (LCH)","histiocytosis","trametinib","paediatric patients","2026-03-24",{"date":93,"type":94},"2026-03-27","ACTUAL",{"date":96,"type":94},"2021-04-01",{"date":98,"type":79},"2027-06-30",{"name":28,"class":6},1]