Evaluating the Long-term Safety and Tolerability of Imatinib in Patients with Lymphangioleiomyomatosis (LAM)

Launched by COLUMBIA UNIVERSITY · Mar 15, 2025

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.