The Safety and Tolerability of Pirfenidone for BOS After HCT (NCT03315741) | Clinical Trial Compass
CompletedPhase 1
The Safety and Tolerability of Pirfenidone for BOS After HCT
United States30 participantsStarted 2018-03-01
Plain-language summary
This is a phase 1, non-randomized, single-arm, open label, single center clinical trial to determine the tolerability and safety of pirfenidone in patients with BOS associated with lung GVHD after hematopoietic cell transplant.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \> 18 years at randomization
. Clinical symptoms (e.g., dyspnea or cough) consistent with BOS of ≥ 2 months duration
. Presence of cGVHD in an organ other than lung
. Subjects must have had recent pulmonary function test (PFTs) measured for at least 3 months prior to study enrollment that show:
. A decrease in %FVC and/or %FEV1 ≥ 20% at Screening compared with pre-transplant baseline.
. Bronchodilator response on PFT testing that results in an FEV1 \< 75%
. Diagnosis of BOS by one of the following criteria:
. Transbronchial or surgical lung biopsy demonstrating the obliterative bronchiolitis lesion
Exclusion criteria
. Any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone e.g., presence of active GVHD of the gastrointestinal tract as manifested by rising liver function tests (LFTs) prior to initiation of study treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of participants that do not require a reduction in drug dose for more than 21 days due to adverse events.