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Extracorporeal Photopheresis for Bronchiolitis Obliterans Syndrome (ECP Trial)
Phase 3
Waitlist Available
Led By George J. Despotis, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of new BOS based on laboratory-based spirometric FEV1 measurements obtained on at least two separate occasions that have declined by more than 20% from post-transplant baseline values
Lung transplant recipient (including combined organ transplant recipients)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
ECP Trial Summary
This trial is studying how well Extracorporeal Photopheresis works in treating patients with either refractory or newly diagnosed Bronchiolitis Obliterans Syndrome after lung transplantation.
Who is the study for?
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.Check my eligibility
What is being tested?
The study is testing Extracorporeal Photopheresis (ECP) effectiveness on patients with either refractory BOS—those not responding to treatments—or newly diagnosed BOS after lung transplantation. It aims to collect data on how well these patients respond to ECP as per Medicare requirements.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed, common ones associated with ECP include reactions at the site where blood is drawn or returned, fever, headache, fatigue, nausea and increased risk of infection.
ECP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with BOS, showing a significant decline in lung function.
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I have received a lung transplant.
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I have been diagnosed with BOS, with two tests showing my lung function has dropped by 20% or more.
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My lung function is decreasing despite treatment.
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My lung function has significantly worsened since being diagnosed with BOS.
Select...
I am 18 years old or older.
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I've had a physical exam and blood test within the last two weeks.
ECP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ annually for five years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~annually for five years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
NEW BOS: Change in the rate of FEV1 decline
NEW BOS: Cumulative All-cause mortality
REFRACTORY BOS: All cause and CLAD related mortality
+1 moreSecondary outcome measures
All Participants: All-cause and CLAD related mortality following either randomization (NEW BOS) or initiation of ECP (Refractory BOS)
All Participants: Average rate of FEV1 decline over the 9 months following initiation of ECP treatment in Refractory BOS or randomization in NEW BOS or the Randomized Control Trial.
All Participants: Change in Health-Related Quality of Life
+8 moreECP Trial Design
2Treatment groups
Experimental Treatment
Group I: Refractory Bronchiolitis Obliterans Syndrome (REFRACTORY BOS)Experimental Treatment1 Intervention
Participants with REFRACTORY BOS will be electronically assigned to either ECP treatment or Observation based on the participant's pre-enrollment Forced Expiratory Volume in 1 second (FEV1). Values from pulmonary function tests from the preceding 12 months will be entered into a web-based treatment allocation which will perform an automated calculation. Patients who have a statistically significant rate of decline within the preceding 6 months, and a derived protocol defined slope, will be assigned to the ECP Treatment arm. If a patient does not meet these criteria, the participant will be assigned to the Observation arm.
Group II: Newly Diagnosed Bronchiolitis Obliterans (NEW BOS)Experimental Treatment1 Intervention
Participants with NEW BOS will be randomized to Early Photopheresis Intervention (EPI) or Control (Standard of Care). EPI patients will receive 24 treatments in a 6-month period and may continue maintenance treatments.
The Control group will receive local Standard of Care for the management of BOS. Therapy will involve changes in immunosuppressive agents.
Find a Location
Who is running the clinical trial?
The Foundation for Barnes-Jewish HospitalOTHER
37 Previous Clinical Trials
6,100 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,940 Previous Clinical Trials
2,302,705 Total Patients Enrolled
4 Trials studying Bronchiolitis Obliterans Syndrome
1,439 Patients Enrolled for Bronchiolitis Obliterans Syndrome
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
15,538 Total Patients Enrolled
3 Trials studying Bronchiolitis Obliterans Syndrome
144 Patients Enrolled for Bronchiolitis Obliterans Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition that may make it hard for you to do breathing tests.I have been diagnosed with BOS, showing a significant decline in lung function.I have not had ECP therapy in the last 6 months.My BOS developed either before 2016 or after 2022.I have a history of disorders related to lymphocyte proliferation.I have not had any cancer, except for skin cancer, in the last 5 years.I have skin or eye conditions that worsen with light-sensitive treatments.Regular monitoring of lung function is needed before diagnosing a new lung condition called BOS.My lung function decline is not due to bronchiolitis obliterans syndrome.I have received a lung transplant.Your lung function has declined too quickly in the last 6 or 9 months.I am part of a trial for a new treatment for BOS.I am 18 years old or older.I have been diagnosed with BOS, with two tests showing my lung function has dropped by 20% or more.My lung function is decreasing despite treatment.I've had a physical exam and blood tests within the last two weeks.My lung function has significantly worsened since being diagnosed with BOS.You need to have at least five recorded breathing test measurements taken at different times over the 9 months before joining the study.You have had regular breathing tests in the past.I have had cancer before.I do not have the natural lens in my eye.I have been treated for sudden worsening of my lung function due to rejection.You have recently had low white blood cell count.Patients must have specific measurements of lung function before and after a lung transplant.My lung function decline is due to restrictive lung issues not related to BOS.I have received ECP Therapy for BOS.I've had a physical exam and blood test within the last two weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Newly Diagnosed Bronchiolitis Obliterans (NEW BOS)
- Group 2: Refractory Bronchiolitis Obliterans Syndrome (REFRACTORY BOS)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it permissible to use this medication according to the FDA?
"The safety of this Phase 3 trial's intervention ranks a 3 on our team's scale at Power. This is due to there being both efficacy data as well as multiple rounds of safety data."
Answered by AI
Are we currently able to sign participants up for this research study?
"Unfortunately, this particular clinical trial is not looking for new candidates at the moment. The information on clinicaltrials.gov suggests that the trial was originally posted on 1/1/2015 and was last updated on 6/20/2022. However, there are many other trials (1465 to be exact) that are actively recruiting patients."
Answered by AI
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