Status:
RECRUITING
Evaluating the Long-term Safety and Tolerability of Imatinib in Patients With Lymphangioleiomyomatosis (LAM)
Lead Sponsor:
Columbia University
Collaborating Sponsors:
United States Department of Defense
Medical University of South Carolina
Conditions:
Lymphangioleiomyomatosis (LAM)
Lymphangioleiomyomatosis
Eligibility:
FEMALE
18-64 years
Phase:
PHASE1
Brief Summary
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 t...
Detailed Description
Lymphangioleiomyomatosis (LAM) is a rare cystic lung disease that is due to a very slow growing cancer that proliferates via unopposed activity of the mTOR pathway. A large NIH study (MILES) found tha...
Eligibility Criteria
Inclusion
- Women 18 through 64 years of age (inclusive)
- Pulmonary Function Test (PFT) with following criteria:
- DLCO \>20% predicted and FVC \<90% OR
- Post bronchodilator FEV1 between 30% and 90% predicted.
- Confirmed or possible diagnosis of LAM
- Willing to avoid grapefruit juice and St. John's wort while in the study
- Able and willing to comply with the study procedures
Exclusion
- Women who have or will undergo a transplant
- Women who will undergo surgery
- Women who are currently pregnant or plan on a pregnancy
- Women who are currently breast feeding or lactating
- 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
- Currently taking any of the following medications:
- Antifungal Medications: Ketoconazole; Itraconazole ; Voriconazole.
- Antibiotics for bacterial infections: Clarithromycin.
- Analgesics to treat headaches/migraines: Dihydroergotamine; Dihydroergotamine intranasal
- Antiretroviral protease inhibitors used in human immunodeficiency virus (HIV) infections: Atazanavir ; Nelfinavir; Indinavir; Ritonavir; Saquinavir
- Anti-epileptic or seizure medications: Carbamazepine, Fosphenytoin; Oxcarbamazepine; Phenobarbital ; Phenytoin; Primidone
- Anti-depressant medications: Nefazodone; St. John's wort
- Targeted cancer drugs: Regorafenib; Venetoclax ; Cobimetinib
- 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).
- Non English speaking, illiterate, or other vulnerable persons will not be included among study subjects.
- Any condition that in the opinion of the investigator might adversely influence the study outcome.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06889168
Start Date
October 1 2025
End Date
March 1 2027
Last Update
August 8 2025
Active Locations (2)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425