Phase 2 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with Langerhans cell histiocytosis (LCH) — either newly diagnosed, or your disease has come back or stopped responding to treatment.
• You are newly diagnosed or have relapsed/refractory LCH and are taking a liquid form of the drug trametinib.
• You have been receiving trametinib as a treatment for LCH since January 1, 2020 (you may be eligible for a records-based review to track long-term outcomes).
• Your diagnosis was confirmed by a biopsy before treatment started.
• Your heart is working well enough, as shown by heart tests (an echocardiogram and an electrocardiogram) done within 30 days of starting treatment, meeting specific measurement thresholds (confirm with trial site).
• You are able to carry out normal daily activities or light activity, as measured by standard performance scales (confirm with trial site).
• Your blood counts, liver, and kidneys are working well enough based on recent blood tests, meeting specific levels (confirm with trial site).
• If you could become pregnant or can father a child, you agree to use effective birth control during the study and for 4 months after the last dose.
• You are able to understand and follow the study procedures for the full length of the trial.

Who may not be able to join:

• Your LCH is considered low-risk — meaning it only affects the skin or a single bone — and does not require treatment, unless the affected area involves specific bones around the skull, spine, or eye socket, the brain, the pituitary gland, or a location where standard local treatment would cause serious harm (confirm with trial site).
• Genetic testing of your disease shows a specific type of gene change called a "Class 3 MAP2K1 mutation" (certain specific mutations listed — confirm with trial site).
• You have yellowing of the skin or eyes (jaundice) at the time of diagnosis.
• You are currently pregnant or breastfeeding, or you receive a positive pregnancy test within 14 days of starting treatment.
• You are allergic to the drug trametinib.
• You currently have a problem with drug or alcohol use that the study team believes would make it hard for you to follow the study requirements.
• You or your parent/legal guardian are unwilling or unable to sign a consent form agreeing to take part in the study.

Important: Always verify eligibility with the trial site directly before applying.