Could a leukemia drug help treat rare lung disease LAM? new trial launches
NCT ID NCT06889168
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 1 trial is testing the long-term safety of imatinib (Gleevec), a drug already approved for leukemia, in 20 women with lymphangioleiomyomatosis (LAM), a rare cystic lung disease. Participants will take either imatinib or a placebo twice daily for 6 months, with regular check-ups. The goal is to see if imatinib is safe and tolerable over a longer period, building on earlier short-term results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- imatinib (Gleevec)
- What this could lead to
- If successful, this could point toward a new treatment option for LAM, a rare lung disease, by showing that imatinib is safe and tolerable over 6 months.
- What could go wrong
- This is a very early, small phase 1 trial with only 20 participants, so results may not apply to everyone. The study focuses on safety, not yet on effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 64 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Columbia University Irving Medical Center
RECRUITINGNew York, New York, 10032, United States
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- France maps a rare lung disease: registry aims to count every LAM case
- Massive TSC data and tissue bank opens to researchers
- Blood markers may guide LAM treatment dosing
- New PET scan could reveal early drug response in rare lung disease
- New registry tracks pregnancy risks in rare genetic disorders
- Could blood particles reveal secrets of rare lung disease LAM?