Phase 3 COPD Trial, Recruiting

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

Who might be able to join this trial:

• People who are 12 years of age or older at the time of giving consent to participate.
• People who have been newly diagnosed with moderate or severe chronic graft-versus-host disease (cGVHD) — a condition that can occur after a stem cell transplant — that requires treatment throughout the body, as defined by a specific set of medical guidelines from 2014.
• People who have previously received a stem cell transplant from a donor (related or unrelated, with any level of tissue matching), using any type of stem cell source (bone marrow, blood stem cells, or cord blood), and under any type of transplant preparation regimen.
• People whose bone marrow is producing enough white blood cells (a specific count of at least 0.5 × 10⁹/L) without the help of growth factor medications, for at least 7 days before joining the study.
• People who are willing to avoid becoming pregnant or fathering children during the trial.

Who may not be able to join:

• People who have had more than one prior donor stem cell transplant (a previous self-donated stem cell transplant is allowed).
• People who have a form of cGVHD that also includes features of acute graft-versus-host disease at the same time (sometimes called "overlap" cGVHD).
• People who have already received more than 7 days of steroid treatment (taken throughout the body) for cGVHD, or who are unable to take a standard steroid dose as required by the trial.
• People who have previously received any systemic (whole-body) treatment for cGVHD, including a procedure called extracorporeal photopheresis.
• People who started certain immune-suppressing medications (CNIs or mTOR inhibitors) within 2 weeks before the trial's first treatment day.
• People who have previously been treated with therapies that target a protein called CSF-1R.
• People who have an active infection (bacterial, fungal, parasitic, or viral) that is not under control.
• People whose original blood disease has come back after the transplant, or who have received any treatment for a relapse after their transplant, including certain immune cell infusions.
• People with a history of acute or chronic inflammation of the pancreas (pancreatitis).
• People who currently have active, symptomatic muscle inflammation (myositis).
• People with a significant or uncontrolled heart condition that could make participation unsafe.
• People with severely reduced kidney function (below a certain level measured by a standard formula), or who are on dialysis due to kidney failure.
• People with significantly reduced liver function, based on specific blood test results, in those who do not have liver cGVHD.
• People who are pregnant or breastfeeding.

Important: Other eligibility criteria not listed here may also apply. Always verify eligibility with the trial site directly before applying.