Extracorporeal Photopheresis for Bronchiolitis Obliterans Syndrome
(ECP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a treatment called Extracorporeal Photopheresis (ECP) for individuals with Bronchiolitis Obliterans Syndrome (BOS), a condition that can develop after a lung transplant. The study aims to determine if ECP can benefit those whose BOS hasn't improved with other treatments or those newly diagnosed. Participants will receive either ECP or standard care to compare outcomes. It suits individuals who have had a lung transplant, are on Medicare, and have a diagnosis of BOS with ongoing lung function decline despite previous treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently participating in another clinical trial or using certain investigational agents, you may be excluded from this study.
What prior data suggests that Extracorporeal Photopheresis is safe for treating Bronchiolitis Obliterans Syndrome?
Research has shown that Extracorporeal Photopheresis (ECP) is generally well-tolerated by patients with bronchiolitis obliterans syndrome (BOS), particularly those unresponsive to treatments like azithromycin. Studies have found promising results with ECP in managing this condition, and no major safety issues have been reported. Additionally, Medicare covers ECP for BOS treatment, indicating confidence in its safety. While ECP is being tested specifically for BOS, its approval for other conditions suggests it is safe for patients.12345
Why do researchers think this study treatment might be promising for Bronchiolitis Obliterans Syndrome?
Researchers are excited about extracorporeal photopheresis (ECP) for bronchiolitis obliterans syndrome (BOS) because it offers a unique approach compared to traditional treatments like immunosuppressive agents. Unlike these standard options, ECP works by modifying immune cells outside the body, potentially reducing inflammation and slowing disease progression without the side effects commonly associated with long-term immunosuppression. This method is particularly appealing because it targets the immune response more precisely, offering hope for patients with refractory BOS who don't respond well to existing treatments.
What evidence suggests that Extracorporeal Photopheresis might be an effective treatment for Bronchiolitis Obliterans Syndrome?
Studies have shown that Extracorporeal Photopheresis (ECP) can effectively treat Bronchiolitis Obliterans Syndrome (BOS), especially in patients unresponsive to standard treatments like azithromycin. In this trial, participants with newly diagnosed BOS will be randomized to receive either early ECP intervention or standard care. Meanwhile, those with refractory BOS will be assigned to either ECP treatment or observation based on specific criteria. Research indicates that ECP may improve lung function, measured by the forced expiratory volume in one second (FEV1), a key indicator of breathing ability. Patients receiving ECP have experienced better survival rates after lung transplants, suggesting a positive impact on long-term health. Additionally, ECP has been linked to a slower decline in lung function, offering hope for those with this challenging condition. Overall, these findings support the potential effectiveness of ECP for treating BOS.12467
Who Is on the Research Team?
George Despotis, MD
Principal Investigator
Washington University St. Louis School of Medicine
Are You a Good Fit for This Trial?
This trial is for Medicare recipients aged 18 or older who have had a lung transplant and are diagnosed with Bronchiolitis Obliterans Syndrome (BOS). They must have documented declines in lung function, frequent spirometry tests, and no history of certain cancers or conditions that would affect the study. Pregnant individuals, those allergic to ECP treatment components, or currently in another BOS clinical trial cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Extracorporeal Photopheresis (ECP) treatment for Bronchiolitis Obliterans Syndrome (BOS). Newly diagnosed BOS patients are randomized to either ECP or standard care.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with spirometry every 30 days for the first year and then annually.
Long-term Follow-up
Participants are followed for long-term outcomes, including mortality and quality of life assessments.
What Are the Treatments Tested in This Trial?
Interventions
- Extracorporeal Photopheresis (ECP)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Therakos, Inc
Collaborator
Centers for Medicare and Medicaid Services/ Coverage and Analysis Group
Collaborator
The Foundation for Barnes-Jewish Hospital
Collaborator
Mallinckrodt
Industry Sponsor
Mario Saltarelli
Mallinckrodt
Chief Medical Officer
MD
Siggi Olafsson
Mallinckrodt
Chief Executive Officer
PhD in Pharmacy
Centers for Medicare and Medicaid Services
Collaborator