Long-term safety of Imatinib for patients with Lymphangioleiomyomatosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the long-term safety and tolerability of Imatinib mesylate in patients diagnosed with Lymphangioleiomyomatosis (LAM), a rare lung disease. The study aims to determine if Imatinib, an FDA-approved drug for leukemia, can effectively induce cell death in LAM cells, potentially offering a new treatment option. Participants will be monitored for their pulmonary function and overall health while receiving either Imatinib or a placebo. The trial seeks to include women aged 18 to 64 with specific pulmonary function test results and confirmed or possible LAM diagnosis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Columbia University Irving Medical Center
  New York, New York, United States Recruiting
• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Jeanine D'Armiento, MD, PhD — Columbia University
• Study coordinator: Katarina Koumbourlis, BS
• Email: kk3922@cumc.columbia.edu
• Phone: 212-305-3745

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.