Evaluating the Long-term Safety and Tolerability of Imatinib in Patients with Lymphangioleiomyomatosis (LAM)
Launched by COLUMBIA UNIVERSITY · Mar 15, 2025
Trial Information
Current as of April 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called a Phase 1 trial, is studying the long-term safety and tolerability of a medication called imatinib for patients with lymphangioleiomyomatosis (LAM), a rare lung disease that can behave like a slow-growing cancer. The trial aims to find out if imatinib can safely help manage this condition, especially since other treatments, like sirolimus, are already being used by many patients. Women aged 18 to 64 who have been diagnosed with LAM and meet certain lung function criteria may be eligible to participate.
If you choose to take part in this trial, you will attend five office visits over six months and have phone check-ins every two weeks. It’s important to note that you will need to avoid certain foods and medications while in the study. This trial is currently recruiting participants, and the goal is to gather valuable information that may help improve treatment options for individuals living with LAM.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Women 18 through 64 years of age (inclusive)
- * Pulmonary Function Test (PFT) with following criteria:
- • 1. DLCO \>20% predicted and FVC \<90% OR
- • 2. 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 Criteria:
- • 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.
Trial Officials
Jeanine D'Armiento, MD, PhD
Principal Investigator
Columbia University
About Columbia University
Columbia University, a prestigious Ivy League institution located in New York City, is a leading sponsor of clinical trials dedicated to advancing medical research and improving patient care. With a robust network of research facilities and a commitment to innovation, Columbia University collaborates with a diverse range of healthcare professionals and researchers to explore groundbreaking therapies and treatment methodologies. The university's clinical trials encompass various fields, including oncology, neurology, and public health, aiming to translate scientific discoveries into effective clinical applications. Columbia University is dedicated to maintaining the highest ethical standards and regulatory compliance, ensuring the safety and well-being of trial participants while contributing to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charleston, South Carolina, United States
New York, New York, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported