BridgeMD
Tests treatment safety and results for Lymphangioleiomyomatosis (LAM)
Official title Evaluating the Long-term Safety and Tolerability of Imatinib in Patients With Lymphangioleiomyomatosis (LAM)
ClinicalTrials.gov ID: NCT06889168
What this study is testing
What is Imatimib Mesylate?
Imatimib Mesylate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for lymphangioleiomyomatosis (lam).
Also referred to as Gleevec®, imatinib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64, women only
You may be able to join if
- Women 18 through 64 years of age (inclusive)
- Pulmonary Function Test (PFT) with following criteria:
- DLCO \>20% predicted and FVC \<90% OR
- Post bronchodilator FEV1 between 30% and 90% predicted.
- Confirmed or possible diagnosis of LAM
You likely can't join if
- 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...
- Currently taking any of the following medications:
See the full eligibility criteria
- Women 18 through 64 years of age (inclusive)
- Pulmonary Function Test (PFT) with following criteria:
- DLCO \>20% predicted and FVC \<90% OR
- 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
- 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)...
- Non English speaking, illiterate, or other vulnerable persons will not be included among study people.
- Any condition that in the opinion of the investigator might adversely influence the study outcome.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.