20 Participants Needed

Imatinib for LAM

(LAMP-2 Trial)

Recruiting at 1 trial location
SH
SP
Overseen BySabrina Palumbo, BS

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications to participate in this trial. Specifically, if you are taking any antifungal medications, certain antibiotics, migraine treatments, HIV medications, anti-seizure drugs, some antidepressants, targeted cancer drugs, or other specified medications, you will not be eligible to join the study.

What data supports the effectiveness of the drug Imatinib Mesylate for LAM?

Imatinib Mesylate is known to be effective in treating certain types of leukemia, such as chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), by targeting specific proteins involved in cancer cell growth. While this data is not directly related to LAM, it suggests that Imatinib's ability to inhibit specific proteins could potentially be beneficial in other conditions.12345

Is Imatinib safe for humans?

Imatinib mesylate is generally considered safe and well-tolerated, but it can cause side effects like nausea, vomiting, diarrhea, muscle cramps, and skin reactions. Some rare but serious side effects include bone marrow problems and skin pigmentation changes. Most side effects are mild and manageable, allowing patients to continue treatment.678910

How is the drug Imatinib Mesylate unique for treating LAM?

Imatinib Mesylate is unique because it is a tyrosine kinase inhibitor, which means it blocks specific enzymes (tyrosine kinases) that promote cell growth, and it is primarily used for treating certain types of leukemia. Its use for LAM (lymphangioleiomyomatosis) is novel as there are no standard treatments specifically approved for this condition.123411

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.

Research Team

JD

Jeanine D'Armiento, MD, PhD

Principal Investigator

Columbia University

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.
See 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
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive imatinib mesylate or placebo over the course of the trial

6 months
5 visits (in-person), check-up phone calls every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants are monitored for long-term safety and changes in biomarkers

1 year

Treatment Details

Interventions

  • Imatinib Mesylate
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Medical University of South Carolina

Collaborator

Trials
994
Recruited
7,408,000+

Findings from Research

In a study of 6 children with chronic myelogenous leukemia (CML) treated with imatinib mesylate for a median of 78.5 months, growth velocity was initially suppressed but improved over time, indicating a potential long-term recovery in growth despite early treatment effects.
The study found that 33.3% of patients had decreased bone mineral density (BMD), which was associated with longer imatinib exposure, and highlighted a high prevalence of vitamin D insufficiency, suggesting that vitamin D supplementation could be beneficial for these patients.
Adverse effects of imatinib in children with chronic myelogenous leukemia.Choeyprasert, W., Yansomdet, T., Natesirinilkul, R., et al.[2017]
Imatinib mesylate (IM) is an effective first-line treatment for chronic myeloid leukemia (CML) that works by inhibiting the bcr-abl fusion protein, but it can cause mild side effects like nausea and muscle cramps.
In some patients, IM can lead to significant skin reactions, such as photoinduced dermatitis and oral lichenoid reactions, which may require discontinuation of the drug or treatment with steroids, highlighting the need for monitoring skin changes during therapy.
Photoinduced dermatitis and oral lichenoid reaction in a chronic myeloid leukemia patient treated with imatinib mesylate.Brazzelli, V., Muzio, F., Manna, G., et al.[2017]
Imatinib mesylate, a drug used to treat chronic myeloid leukemia, may be linked to ischemic maculopathy, which can lead to significant vision problems, as demonstrated in a case study of a 62-year-old woman.
The patient developed severe visual impairment and retinal abnormalities after starting imatinib therapy, highlighting the need for careful monitoring of patients for visual symptoms while on this medication.
Macular ischemia associated with imatinib mesylate therapy for chronic myeloid leukemia.Roth, DB., Akbari, S., Rothstein, A.[2014]

References

Adverse effects of imatinib in children with chronic myelogenous leukemia. [2017]
The effect of dose increase of imatinib mesylate in patients with chronic or accelerated phase chronic myelogenous leukemia with inadequate hematologic or cytogenetic response to initial treatment. [2023]
Photoinduced dermatitis and oral lichenoid reaction in a chronic myeloid leukemia patient treated with imatinib mesylate. [2017]
Macular ischemia associated with imatinib mesylate therapy for chronic myeloid leukemia. [2014]
Improved early event-free survival with imatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia: a children's oncology group study. [2022]
Imatinib-related bone marrow aplasia after complete cytogenetic response in chronic myeloid leukemia. [2015]
Analysis of adverse drug reactions of imatinib in chronic myeloid leukemia patients: An Eastern Indian experience. [2023]
Skin lesions in patients treated with imatinib mesylate: a 5-year prospective study. [2017]
Hyperpigmentation due to imatinib: A rare case of cutaneous involvement. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Imatinib mesylate causes hypopigmentation in the skin. [2022]
Skin and oral lesions associated to imatinib mesylate therapy. [2021]
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