Imatinib for LAM
(LAMP-2 Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJeanine D'Armiento, MD, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Columbia University

Trial Summary

What is the purpose of this trial?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

This trial is for individuals with a rare lung disease called Lymphangioleiomyomatosis (LAM). Participants must have been previously treated with sirolimus, as the study examines the effects of Imatinib Mesylate, a drug used in leukemia treatment that may cause LAM cell death. The trial involves office visits and bi-weekly phone check-ups over 6 months.

Inclusion Criteria

Able and willing to comply with the study procedures

I am a woman aged between 18 and 64.

My lung function tests show specific levels of breathing capacity.

+2 more

Exclusion Criteria

I am a woman scheduled for surgery.

Dementia or other cognitive dysfunction that would prevent the participant from consenting to the study or completing study procedures

Non English speaking, illiterate, or other vulnerable persons

+5 more

Participant Groups

The study tests the long-term safety and tolerability of Imatinib Mesylate compared to a placebo in treating LAM. It follows up on earlier research suggesting benefits from this medication. Over six months, participants will receive either Imatinib or a placebo while their health is closely monitored.

2Treatment groups

Active Control

Placebo Group

Group I: Imatinib Mesylate GroupActive Control1 Intervention

This group will receive imatinib mesylate over the course of the trial.

Group II: Placebo GroupPlacebo Group1 Intervention

This group will receive placebo over the course of the trial.