[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphangioleiomyomatosis-lam\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphangioleiomyomatosis-lam":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100584425","phase-1-evaluating-the-long-term-safety-and-tolerability-of-imatinib-in-patients-with-lymphangioleiomyomatosis-lam-100584425",false,"NCT06889168","Evaluating the Long-term Safety and Tolerability of Imatinib in Patients With Lymphangioleiomyomatosis (LAM)","A Phase 1, Randomized, Double-blinded, Placebo Controlled, Trial Evaluating the Long-term Safety and Tolerability of Imatinib for the Treatment of Lymphangioleiomyomatosis [LAMP-2 Trial]","LAMP-2","Inclusion Criteria:\n\n* Women 18 through 64 years of age (inclusive)\n* Pulmonary Function Test (PFT) with following criteria:\n\n  1. DLCO \\>20% predicted and FVC \\\u003C90% OR\n  2. Post bronchodilator FEV1 between 30% and 90% predicted.\n* Confirmed or possible diagnosis of LAM\n* Willing to avoid grapefruit juice and St. John's wort while in the study\n* Able and willing to comply with the study procedures\n\nExclusion Criteria:\n\n* Women who have or will undergo a transplant\n* Women who will undergo surgery\n* Women who are currently pregnant or plan on a pregnancy\n* Women who are currently breast feeding or lactating\n* Dementia or other cognitive dysfunction that, in the opinion of the investigator, would prevent the participant from consenting to the study or completing study procedures\n* Currently taking any of the following medications:\n\n  * Antifungal Medications: Ketoconazole; Itraconazole ; Voriconazole.\n  * Antibiotics for bacterial infections: Clarithromycin.\n  * Analgesics to treat headaches\u002Fmigraines: Dihydroergotamine; Dihydroergotamine intranasal\n  * Antiretroviral protease inhibitors used in human immunodeficiency virus (HIV) infections: Atazanavir ; Nelfinavir; Indinavir; Ritonavir; Saquinavir\n  * Anti-epileptic or seizure medications: Carbamazepine, Fosphenytoin; Oxcarbamazepine; Phenobarbital ; Phenytoin; Primidone\n  * Anti-depressant medications: Nefazodone; St. John's wort\n  * Targeted cancer drugs: Regorafenib; Venetoclax ; Cobimetinib\n  * Ivabradine (used to treat chronic heart failure); Telithromycin (used to treat community acquired pneumonia); Lomitapide (treatment of familial hypercholesterolemia); Lonafarnib (Hutchinson-Gilford progeria syndrome); conivaptan (treat low sodium levels); flibanserin (management of hypoactive sexual desire disorder (HSDD)); Naloxegol (opioid-induced constipation); Warfarin (prevent blood clots); Lurasidone (schizophrenia and bipolar depression); Eliglustat (treatment of Gaucher's disease).\n* Non English speaking, illiterate, or other vulnerable persons will not be included among study subjects.\n* Any condition that in the opinion of the investigator might adversely influence the study outcome.","FEMALE","18 Years","64 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Lymphangioleiomyomatosis (LAM) is a rare cystic lung disease that appears to behave like a slowly growing cancer. Since clinical progression is very slow, new blood tests have been used to speed the time required to find safe and effective medications. A large National Institute of Health study called MILES showed that sirolimus (also known as Rapamycin) improved lung function in individuals with LAM. Since most individuals with LAM and impaired lung function are now on sirolimus, future studies may prove more difficult. Laboratory studies suggested that Imatinib mesylate (imatinib), an FDA-approved drug for leukemia, initiates LAM cell death. A pilot trial with imatinib titled \"Imatinib Mesylate for the treatment of Lymphangioleiomyomatosis\" - (LAMP-1) was funded by the Department of Defense in 2016, and documented (1) the safety of use of tyrosine kinase inhibitors in patients with LAM; (2) the safety of concurrent use of tyrosine kinase and mTOR inhibitors; and, (3) short term variability in vascular endothelial growth factor D (VEGF-D) - a LAM biomarker, as a response to therapies. Due to the short-term LAMP-1 trial, LAMP-2 will be a longer-term 6-month clinical study evaluating the safety and tolerability of imatinib in patients with LAM. Patients that participate in the trial will come in for 5 office visits and check-up phone calls every 2 weeks over the course of 6 months.",[28,29],"Lymphangioleiomyomatosis (LAM)","Lymphangioleiomyomatosis",[31,15,32],"LAM","Imatinib","RECRUITING","2026-01-19",{"date":36,"type":37},"2026-01-21","ACTUAL",{"date":39,"type":37},"2025-10-20",{"date":41,"type":22},"2027-03",{"name":43,"class":44},"Columbia University","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100616380","role-of-extracellular-vesicles-as-biomarkers-of-pulmonary-involvement-in-patients-with-lymphangioleiomyomatosis-and-tuberous-sclerosis-complex-100616380","NCT07304856","Role of Extracellular Vesicles as Biomarkers of Pulmonary Involvement in Patients With Lymphangioleiomyomatosis and Tuberous Sclerosis Complex","Prospective Observational Study of the Role of Extracellular Vesicles (EVs) as Biomarkers of Pulmonary Involvement in Patients With Sporadic Lymphangioleiomyomatosis (S-LAM) and Tuberous Sclerosis Complex-Associated LAM (TSC-LAM)","Inclusion Criteria:\n\nFemale participants aged ≥18 years Confirmed diagnosis of tuberous sclerosis complex (TSC) and\u002For lymphangioleiomyomatosis (definite diagnosis of TSC-LAM or S-LAM) Follow-up at the Pulmonology Unit of ASST Santi Paolo e Carlo, Milan Ability to provide written informed consent\n\nExclusion Criteria:\n\nDiagnosis of \"probable\" or \"possible\" LAM Refusal to provide written informed consent",true,"80 Years",{"count":55,"type":22},80,"OBSERVATIONAL","Lymphangioleiomyomatosis (LAM) is a rare lung disease, linked to Tuberous Sclerosis Complex (TSC) or occurring sporadically, and involves abnormal mTORC1 activation. LAM cells are neoplastic, and recent focus has turned to extracellular vesicles (EVs), which mediate tumor progression and may serve as biomarkers. This study, conducted at the Pulmonology Unit of ASST Santi Paolo e Carlo and the Pharmacology Laboratory of the University of Milan, will analyze the characteristics of serum EVs in patients with LAM and TSC. During scheduled outpatient visits, clinical and functional data and blood samples will be collected. Plasma will be separated, and EVs will be isolated via centrifugation. EVs will be analyzed for size, concentration, and molecular content (proteins, lipids, nucleic acids). The results obtained will be collected and correlated with the clinical and functional data.",[28,59],"Extracellular Vesicles; Generation and Function",[61],"LAM, TSC, EVs","2025-12-12",{"date":64,"type":37},"2025-12-26",{"date":66,"type":37},"2025-04-16",{"date":68,"type":22},"2026-08-20",{"name":70,"class":44},"University of Milan",1]