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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)

Must not have

History of receiving ECP therapy within 6 months prior to enrollment

Development of BOS before 2016 or after 2022

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had ECP therapy in the last 6 months.

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My BOS developed either before 2016 or after 2022.

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I have a history of disorders related to lymphocyte proliferation.

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I have skin or eye conditions that worsen with light-sensitive treatments.

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I have had cancer before.

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I do not have the natural lens in my eye.

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My lung function decline is due to restrictive lung issues not related to BOS.

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I have received ECP Therapy for BOS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ annually for five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~annually for five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and annually for five years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

NEW BOS: Change in the rate of FEV1 decline

NEW BOS: Cumulative All-cause mortality

REFRACTORY BOS: All cause and CLAD related mortality

+1 more

Secondary study objectives

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 more

Awards & Highlights

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.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Standard of Care Comparator Retrospective Chart reviewExperimental Treatment1 Intervention

Data for the SOC comparator will be obtained via a retrospective data capture mechanism either medical chart review or electronic medical record query that meet all of the inclusion criteria and through an IRB approved waiver of consent. The SOC comparator data will be identical to the data collected for the Refractory BOS patients with the exception of inclusion of all spirometry values after transplant.

Group II: 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. Two hundred and fifty-eight (258) participants were enrolled with Refractory BOS nationwide.

Group III: 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. Twenty-two (22) NEW BOS participants were enrolled nationwide. The Control group will receive local Standard of Care for the management of BOS. Therapy will involve changes in immunosuppressive agents.

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centers for Medicare and Medicaid Services/ Coverage and Analysis GroupFED

1 Previous Clinical Trials

8,680 Total Patients Enrolled

The Foundation for Barnes-Jewish HospitalOTHER

41 Previous Clinical Trials

6,233 Total Patients Enrolled

Washington University School of MedicineLead Sponsor

1,997 Previous Clinical Trials

2,298,481 Total Patients Enrolled

MallinckrodtIndustry Sponsor

201 Previous Clinical Trials

15,586 Total Patients Enrolled

Centers for Medicare and Medicaid ServicesFED

40 Previous Clinical Trials

31,233,621 Total Patients Enrolled

George J. Despotis, M.D.Principal InvestigatorWashington University St. Louis School of Medicine

Media Library

Extracorporeal Photopheresis (ECP) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02181257 — Phase 3

$BOS Research Study Groups: Standard of Care Comparator Retrospective Chart review, Newly Diagnosed Bronchiolitis Obliterans (NEW BOS), Refractory Bronchiolitis Obliterans Syndrome (REFRACTORY BOS)$