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NCT06889168 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Long-term Safety and Tolerability of Imatinib in Patients With Lymphangioleiomyomatosis (LAM)
A Phase 1 study of Lymphangioleiomyomatosis and Lymphangioleiomyomatosis (LAM), sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT06889168 is a Phase 1 study of Lymphangioleiomyomatosis and Lymphangioleiomyomatosis (LAM) that is actively recruiting participants, run by Columbia University. The registered enrollment target is 20 participants, below the 828-participant average among 10 other Lymphangioleiomyomatosis trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06889168, a Phase 1 study of Lymphangioleiomyomatosis and Lymphangioleiomyomatosis (LAM), is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Imatimib Mesylate
Study Locations (2)
New York
- Columbia University Irving Medical Center - New York
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-10-20 |
| Est. Completion | 2027-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06889168
The ClinicalTrials.gov registry entry for NCT06889168 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 828-participant average among 10 other Lymphangioleiomyomatosis trials with a reported enrollment target (98% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Lymphangioleiomyomatosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06889168 reports 2 study locations spanning 2 distinct geographic areas - top geographies include New York, South Carolina.
Frequently Asked Questions
What is clinical trial NCT06889168 about?
NCT06889168 is a clinical study titled "Evaluating the Long-term Safety and Tolerability of Imatinib in Patients With Lymphangioleiomyomatosis (LAM)". 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 call...
What is the current status of trial NCT06889168?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2025-10-20. Estimated completion is 2027-03.
What conditions does trial NCT06889168 study?
This clinical trial studies the following conditions: Lymphangioleiomyomatosis, Lymphangioleiomyomatosis (LAM).
What interventions are being tested in trial NCT06889168?
The interventions under investigation include: Placebo (DRUG), Imatimib Mesylate (DRUG).
Who is sponsoring clinical trial NCT06889168?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06889168 being conducted?
This trial has 2 study locations across New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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