Long-term safety of Imatinib for patients with Lymphangioleiomyomatosis
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]
This study is testing if the cancer drug Imatinib is safe and can help women with Lymphangioleiomyomatosis by seeing how it affects their lung health over time.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | Cobimetinib, Imatinib, nilotinib |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06889168 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 64 with a confirmed or possible diagnosis of LAM and specific pulmonary function test results.
Not a fit: Patients who are currently pregnant, breastfeeding, or have undergone a transplant or surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for patients with LAM, improving their lung function and quality of life.
How similar studies have performed: Previous studies have shown promising results with similar approaches, particularly the pilot trial LAMP-1, which documented the safety of tyrosine kinase inhibitors in LAM patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.