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Could a leukemia drug help treat rare lung disease LAM? new trial launches

NCT ID NCT06889168

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 64 years

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

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