Phase 1 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 willing and able to sign a written consent form before any study-related screening takes place
• People who are 18 years of age or older at the time of signing consent
• People who have previously received a stem cell transplant (using bone marrow, blood stem cells, or cord blood) from a donor — including a matched unrelated donor, a sibling, or a half-matched donor
• People whose blood counts meet minimum levels: a neutrophil count of at least 750/mm³, a platelet count of at least 40,000/mm³, and a haemoglobin level of at least 8.0 g/dL (note: growth factor support to help reach these levels is permitted)
• People who have been clinically diagnosed with mild to severe chronic Graft-versus-Host Disease (cGvHD) — a condition where donated cells attack the recipient's body — and whose cGvHD has not responded well to steroid treatment, meeting at least one of these conditions:
  • The disease got worse despite receiving a relatively high steroid dose for at least one week
  • The disease persisted despite ongoing steroid treatment at a moderate dose for at least four weeks
  • Steroids had to be increased again after an unsuccessful attempt to reduce the dose
  • The cGvHD came back after a complete response to treatment
  • The cGvHD progressed after a partial response to treatment
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (meaning people who are fully active, have some limitations but can care for themselves, or are up and about more than half their waking hours)

Who may not be able to join:

• People who have been treated with ruxolitinib (a medication) for cGvHD for more than three weeks before the planned start of the study
• People who have previously been treated with fostamatinib or a similar type of drug (called a SYK inhibitor) specifically for acute or chronic GvHD (prior use of fostamatinib for other conditions is permitted)
• People who are currently receiving any other ongoing systemic (whole-body) treatment for cGvHD beyond steroids, a calcineurin inhibitor, or mycophenolate mofetil — except for fewer than three weeks of ruxolitinib
• People whose original blood cancer or condition has come back, or who have received treatment for a relapse after their transplant
• People whose cGvHD developed following an unscheduled donor lymphocyte infusion (an infusion of donor immune cells given to prevent cancer from returning) — though people who received a scheduled infusion as a planned part of their transplant process may still be eligible
• People with a history of a serious brain condition called progressive multifocal leukoencephalopathy (PML)
• People with an active infection (bacterial, fungal, parasitic, or viral) that is not currently under control with appropriate treatment
• People with active and significant viral illnesses including HIV, CMV, HHV-6, hepatitis B, hepatitis C, or BK virus
• People who require a breathing machine or whose blood oxygen level is below 90% at rest
• People with serious, uncontrolled heart conditions, including unstable chest pain, a heart attack or stroke within the past three months, or severe heart failure
• People with high blood pressure that is not under control (systolic above 160 mmHg or diastolic above 100 mmHg)
• People with significantly reduced kidney function below a certain threshold who are not on dialysis (confirm with trial site)
• People with significantly elevated liver test results above certain thresholds (confirm with trial site)
• People with a specific abnormality in heart rhythm measurements above a set level on an ECG (confirm with trial site)
• People who are currently pregnant, breastfeeding, or actively trying to become pregnant
• People whom the trial doctor believes may not be able to follow the study procedures for any reason

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