NCT06889168 Evaluating the Long-term Safety and Tolerability of Imatinib in Patients With Lymphangioleiomyomatosis (LAM)
| NCT ID | NCT06889168 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Columbia University |
| Condition | Lymphangioleiomyomatosis (LAM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-10-20 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-10-20 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 time required to find safe and effective medications. A large National Institute of Health study called MILES showed that sirolimus (also known as Rapamycin) improved lung function in individuals with LAM. Since most individuals with LAM and impaired lung function are now on sirolimus, future studies may prove more difficult. Laboratory studies suggested that Imatinib mesylate (imatinib), an FDA-approved drug for leukemia, initiates LAM cell death. A pilot trial with imatinib titled "Imatinib Mesylate for the treatment of Lymphangioleiomyomatosis" - (LAMP-1) was funded by the Department of Defense in 2016, and documented (1) the safety of use of tyrosine kinase inhibitors in patients with LAM; (2) the safety of concurrent use of tyrosine kinase and mTOR inhibitors; and, (3) short term variability in vascular endothelial growth factor D (VEGF-D) - a LAM biomarker, as a response to therapies. Due to the short-term LAMP-1 trial, LAMP-2 will be a longer-term 6-month clinical study evaluating the safety and tolerability of imatinib in patients with LAM. Patients that participate in the trial will come in for 5 office visits and check-up phone calls every 2 weeks over the course of 6 months.
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.
Contact & Investigator
Jeanine D'Armiento, MD, PhD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06889168 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 64 Years, studying Lymphangioleiomyomatosis (LAM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06889168 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06889168 currently recruiting?
Yes, NCT06889168 is actively recruiting participants. Contact the research team at kk3922@cumc.columbia.edu for enrollment information.
Where is the NCT06889168 trial being conducted?
This trial is being conducted at New York, United States, Charleston, United States.
Who is sponsoring the NCT06889168 clinical trial?
NCT06889168 is sponsored by Columbia University. The principal investigator is Jeanine D'Armiento, MD, PhD at Columbia University. The trial plans to enroll 20 participants.