[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rosai-dorfman-disease-rdd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rosai-dorfman-disease-rdd":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100527854","phase-2-mirdametinib-in-histiocytic-disorders-100527854",false,"NCT06153173","Mirdametinib in Histiocytic Disorders","A Phase II Trial of the MEK Inhibitor Mirdametinib in Histiocytic Disorders","Inclusion Criteria:\n\n1. Subjects must be ≥ 2 years of age AND have a diagnosis of a histiocytic disorder that requires systemic therapy\n\n   * If patient has had a diagnostic biopsy, biopsy must be reviewed and confirmed by CCHMC pathologist as feasible\n   * If patient has had a biopsy but has not had molecular testing done, must have tissue available for mutational analysis\n   * If patient has isolated pituitary\u002FCNS disease or situations where biopsy is not feasible, positive ddPCR blood test for mutation associated with histiocytic neoplasm with clinical features of histiocytosis is sufficient\n2. Must have measurable disease on PET scan or brain MRI\n3. Subjects must demonstrate adequate organ function as defined:\n\n   * Renal: maximum serum creatinine 2x the upper limit of normal (ULN) OR a creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m2\n   * Liver: ALT ≤ 3x ULN AND normal INR (≤ 1.5)\n   * Hematologic: Hematology: Albumin ≥ 2.8 g\u002FdL; Absolute neutrophil count ≥ 1.5 x 109\u002FL; Platelets ≥ 100 x 109\u002FL; Hemoglobin ≥ 9.0 g\u002FdL\n   * Patients with organ function abnormalities outside of these thresholds deemed to be the result of histiocytic disease will be considered eligible\n\nExclusion Criteria:\n\n1. Prior therapy with stipulations as described:\n\n   * Myelosuppressive Chemotherapy: Must not have received any cytotoxic chemotherapy which impacts the growth and development of cells in the bone marrow within 14 days of enrollment onto this study (i.e. cytarabine, cladribine, clofarabine, mercaptopurine, methotrexate, vinblastine)\n   * MEK Inhibitors: Must not have received a MEK inhibitor within 30 days (or 5 half-lives, whichever is longer) of enrollment, NOR have had disease progression on MEK inhibitor\n   * Steroids: Due to the increased risk of an ocular event, the use of systemic oral, inhaled, or ocular glucocorticoid therapy is prohibited within 14 days prior to first dose of mirdametinib. Throughout the treatment period, short term glucocorticoid treatment (30 days or less) is permitted. Any patients requiring long-term steroid use (more than 30 consecutive days) are not eligible. The exception to this rule is subjects with endocrine deficiencies who require physiologic steroids\n   * Radiation: Must not have received radiation within 14 days of study enrollment or have received radiation to the orbit at any time\n2. Risk factors for retinal vein occlusion (RVO) are listed. Exclusion should be considered by clinical discretion if they have any of the following risk factors for RVO at screening:\n\n   * Intraocular pressure (IOP) \\> 21 mmHg; if IOP is unable to be obtained (eg age, cooperation, tolerability), ophthalmologist's exam findings and overall assessment will be utilized. If in the ophthalmologist's assessment there are no signs of raised IOP, the subject will be considered eligible for this parameter\n   * Glaucoma or any significant abnormality (≥ grade 2) on ophthalmologic exam that is uncontrolled with intervention\n   * Serum cholesterol \\> 300 mg\u002FdL\n   * Serum triglycerides \\> 300 mg\u002FdL\n   * Hyperglycemia (either fasting blood glucose \\> 125 mg\u002FdL OR random blood glucose \\> 200 mg\u002FdL)\n   * Uncontrolled hypertension (participants ≤ 12 years of age with a blood pressure ≥ 95th percentile for age + 12 mmHg; participants ≥ 13 years of age with a blood pressure ≥ 140\u002F90 mm Hg) unresolved on repeat measurement\n3. LVEF \\\u003C 55% at screening OR history of clinically significant cardiac disease, unless deemed to be the direct result of disease\n4. Subjects who are pregnant or breastfeeding, or are at risk of pregnancy or fathering a baby and are unable to use acceptable methods of birth control during the length of the study","ALL","2 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to see if treatment with mirdametinib in patients with Langerhans cell histiocytosis (LCH) or other histiocytic disorders will be better than current treatments and with fewer side effects.",[26,27,28,29],"Langerhans Cell Histiocytosis (LCH)","Juvenile Xanthogranuloma (JXG)","Rosai-Dorfman Disease (RDD)","Histiocytic Disorders","RECRUITING","2025-09-10",{"date":33,"type":34},"2025-09-16","ACTUAL",{"date":36,"type":34},"2024-02-05",{"date":38,"type":20},"2031-03",{"name":40,"class":41},"Children's Hospital Medical Center, Cincinnati","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100231051","international-rare-histiocytic-disorders-registry-irhdr-100231051","NCT02285582","International Rare Histiocytic Disorders Registry (IRHDR)","IRHDR","Inclusion Criteria:\n\n1. Any age at diagnosis.\n2. Diagnosis of a rare histiocytic disorder, established before or after the opening of the registry.\n3. Cases diagnosed from January - 01- 1995 until the present time and prospectively.\n4. Signed informed consent by a patient, or parent\u002Flegal guardian.\n5. Cognitively impaired patients can be included after consent by legal guardian\u002Fparent.\n6. Deceased patients can be included if they are contacted at least 6 months after the death of their child and not on their child's birthday or anniversary of death.\n\nExclusion Criteria:\n\n1. Informed consent has not been signed.\n2. Diagnosis other than RHD.\n3. Cases diagnosed before the year 1995.",{"count":51,"type":20},400,"10 Years","OBSERVATIONAL","The rare histiocytic disorders (RHDs) are characterized by the infiltration of one or more organs by non-LCH histiocytes. They can range from localized disease that resolves spontaneously, to progressive disseminated forms that can be sometimes life-threatening. Since they are extremely rare, there is limited understanding of their causes and best treatment options. Physicians, patients and parents of children with RHDs frequently consult members of the Histiocyte Society regarding the best management of these disorders. Very often, no specific recommendation can be made due to the lack of prospective outcome data, or even large retrospective case series. The creation of an international rare histiocytic disorders registry (IRHDR) could facilitate a uniform diagnosis of the RHDs, as well as the collection and analysis of the clinical, epidemiological, treatment and survival data of patients with RHD. The registry may also lead to future therapeutic recommendations, provide a framework for future clinical trials and create excellent research opportunities.",[56,57,28,58,59,60,61,62,63,64],"Rare Histiocytic Disorders (RHDs)","Erdheim-Chester Disease (ECD)","Xanthogranuloma Family (XG)","Indeterminate Dendritic Cell Histiocytosis","Malignant Histiocytic Neoplasm (MHN)","ALK-positive Histiocytosis","Mixed Histiocytosis (MXH)","Multicentric Reticulohistiocytoma (MRH)","Necrobiotic Xanthogranuloma (NX)","2025-06-18",{"date":67,"type":34},"2025-06-24",{"date":69,"type":4},"2014-10",{"date":71,"type":20},"2028-09",{"name":73,"class":41},"The Hospital for Sick Children",15]