[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"histiocytosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:histiocytosis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,92,125,153,173,195],{"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":25,"conditions":26,"keywords":59,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100499720","phase-1-phase-12-trial-of-s241656-in-selected-rasmapk-mutation--positive-malignancies-100499720",false,"NCT05786924","Phase 1\u002F2 Trial of S241656 in Selected RAS\u002FMAPK Mutation- Positive Malignancies","A Phase 1\u002F2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS\u002FMAPK Mutation-Positive Malignancies","Key Inclusion Criteria:\n\n* Life expectancy of ≥ 12 weeks in the opinion of the investigator.\n* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.\n* Adequate bone marrow and organ function.\n* Recovered from toxicity to prior anti-cancer therapy.\n\nPart 1 Dose Escalation cohort ONLY:\n\n* Part 1A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations\n* Part 1B: Advanced\u002Fmetastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1C: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1E: Other advanced\u002Fmetastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations\n\nPart 2 Dose Optimization and Expansion cohorts ONLY:\n\n* Part 2A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations and\u002For BRAF mutations\n* Part 2A1: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations\n* Part 2A2: Advanced\u002Fmetastatic NSCLC with BRAF mutations\n* Part 2A3: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease\n* Part 2A4: Advanced\u002Fmetastatic NSCLC with a KRAS G12C mutation\n* Part 2B1: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B2: Advanced\u002Fmetastatic CRC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B3: Advanced\u002Fmetastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n\nKey Exclusion Criteria:\n\n* Cancer that has a known MEK1\u002F2 mutation.\n* Known allergy\u002Fhypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.\n* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.\n* Major surgery within 4 weeks of study entry or planned during study.\n* Ongoing anticancer therapy.\n* Ongoing radiation therapy.\n* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.\n* Clinically significant cardiovascular disease.\n* Symptomatic spinal cord compression.\n* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.\n* Females who are pregnant or breastfeeding.\n* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.\n* Prior use of experimental agents that target the KRAS\u002FBRAF\u002FMEK\u002FERK pathway.","ALL","18 Years",{"count":19,"type":20},554,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","BDTX-4933-101 is a first-in-human, open-label, Phase 1\u002F2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced\u002Fmetastatic NSCLC with KRAS and\u002For BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58],"Non-small Cell Lung Cancer","Histiocytic Neoplasm","Histiocytosis","BRAF Gene Mutation","BRAF V600E","BRAF V600 Mutation","BRAF Mutation-Related Tumors","BRAF","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Lung Cancer","Recurrent Lung Cancer","Recurrent Lung Non-Small Cell Carcinoma","NSCLC","Solid Tumor","Solid Carcinoma","KRAS G12D","KRAS G12V","KRAS Mutation-Related Tumors","NRAS Gene Mutation","Thyroid Cancer","Thyroid Carcinoma","Colorectal Cancer","Colorectal Carcinoma","Recurrent Histiocytic and Dendritic Cell Neoplasm","Brain Metastases","Recurrent NSCLC","KRAS G13C","Acquired Resistance to KRAS G12C Inhibitor","KRAS G12A","KRAS G12F","KRAS G12R","KRAS G13D",[60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78],"BRAF Class I","BRAF Class II","BRAF Class III","KRAS","Intolerant histiocytic neoplasm","BDTX-4933","Phase 1","dose escalation","dose expansion","MAPK","mitogen-activated protein kinase","RAS","RAF","Upstream oncogenic alterations","RAF inhibitor","intracranial disease","CRAF","NRAS","RAF fusions","RECRUITING","2026-06-16",{"date":82,"type":83},"2026-06-17","ACTUAL",{"date":85,"type":83},"2023-04-18",{"date":87,"type":20},"2028-06",{"name":89,"class":90},"Institut de Recherches Internationales Servier","OTHER",27,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":103,"conditions":104,"keywords":110,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100509575","histiocytic-disorder-follow-up-study-100509575","NCT05915208","Histiocytic Disorder Follow-up Study","Inclusion Criteria:\n\n* diagnosis of histiocytic disorder at any age\n\n  1. Langerhans cell histiocytosis,\n  2. Erdheim-Chester disease,\n  3. Rosai-Dorfman disease,\n  4. Xanthogranuloma,\n  5. Mixed histiocytosis\n  6. Malignant histiocytosis (Histiocytic sarcoma, langerhans cell sarcoma, interdigitating cell sarcoma)\n  7. Hemophagocytic lymphohistiocytosis\n\nExclusion Criteria:\n\n* None","0 Years","89 Years",{"count":101,"type":20},6000,"OBSERVATIONAL","The purpose of the study is to describe the burden of chronic health conditions, psychological dysfunction, chronic pain, healthcare utilization, worse health-related quality of life, overall mortality, and cause-specific mortality among individuals with histiocytic disorders",[29,105,106,107,108,109],"Langerhans Cell Histiocytosis","Erdheim-Chester Disease","Rosai Dorfman Disease","Xanthogranuloma","Malignant Histiocytoses",[111,112,113,114],"survivorship","long-term","targeted therapy","second cancer","2026-06-10",{"date":117,"type":83},"2026-06-12",{"date":119,"type":83},"2022-09-01",{"date":121,"type":20},"2028-12",{"name":123,"class":90},"University of Alabama at Birmingham",1,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":133,"maxAge":17,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":124},"100434902","phase-2-optimization-of-the-time-and-dosage-of-trametinib-in-braf-negative-juvenile-patients-100434902","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.","1 Year",{"count":135,"type":20},12,[24],"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.",[29],[140,141,142,143],"Langerhans cell histiocytosis (LCH)","histiocytosis","trametinib","paediatric patients","2026-03-24",{"date":146,"type":83},"2026-03-27",{"date":148,"type":83},"2021-04-01",{"date":150,"type":20},"2027-06-30",{"name":152,"class":90},"Anna Raciborska",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":133,"maxAge":17,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":171,"leadSponsor":172,"locationsCount":124},"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":161,"type":20},25,[24],"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.",[29],[140,166,167,168,143],"vemurafenib","children","refractory histiocytosis",{"date":146,"type":83},{"date":148,"type":83},{"date":150,"type":20},{"name":152,"class":90},{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":133,"maxAge":17,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":193,"leadSponsor":194,"locationsCount":124},"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":182,"type":20},150,[184],"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.",[29],[140,141,188,189,143],"Positron Emission Tomography (PET)","molecular status",{"date":191,"type":83},"2026-03-25",{"date":148,"type":83},{"date":150,"type":20},{"name":152,"class":90},{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":202,"targetDuration":204,"studyType":102,"phases":4,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":124},"100413598","adult-pulmonary-langerhans-cell-histiocytosis-a-national-registry-based-prospective-cohort-study-100413598","NCT04665674","Adult Pulmonary Langerhans Cell Histiocytosis: a National Registry-based Prospective Cohort Study","Enquête épidémiologique Sur la prévalence et le Pronostic de l'Histiocytose Langerhansienne Pulmonaire de l'Adulte en France","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Diagnosis of PLCH was either histologically confirmed on a biopsy of an involved tissue, or based on the combination of the following criteria: 1) an appropriate clinical picture; 2) a typical nodulo-cystic pattern on lung high-resolution computed tomography (HRCT) and 3) exclusion of alternative diagnoses\n\nExclusion Criteria:\n\n\\-",{"count":203,"type":20},500,"30 Years","The long-term outcomes of adult patients with pulmonary Langerhans cell histiocytosis (PLCH), particularly survival, is largely unknown. This is the first prospective study in the field evaluating the long-term outcomes of PLCH patients. This french countrywide registry-based study included a large cohort of PLCH patients followed for a sufficiently long period to address risk factors of long-term outcomes of PLCH patients.",[29,207,208],"Histiocytosis, Langerhans-Cell","Histiocytosis Pulmonary","2020-12-15",{"date":211,"type":83},"2020-12-17",{"date":213,"type":83},"2004-01-01",{"date":215,"type":20},"2035-12-31",{"name":217,"class":90},"Assistance Publique - Hôpitaux de Paris"]