Clinical Trial: Extracorporeal Photopheresis for the Management of Progressive Bronchiolitis Obliterans Syndrome in Medicare-Eligible Recipients of Lung Allografts

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational [Patient Registry]

Official Title: Extracorporeal Photopheresis for the Management of Progressive Bronchiolitis Obliterans Syndrome in Medicare-Eligible Recipients of Lung Allografts

Brief Summary:

The purpose of this study is to determine if Extracorporeal Photopheresis (ECP) is effective in the treatment of progressive Bronchiolitis Obliterans Syndrome (BOS) in patients after lung transplantation. Lung transplantation has become the treatment of choice for selected patients with end-stage lung disease. However, long-term survival after transplantation remains disappointing. Chronic rejection (bronchiolitis obliterans syndrome [BOS]) has emerged as the leading obstacle to better long-term outcomes, and represents the leading cause of death beyond the first year after transplantation. BOS is diagnosed by the decline in the FEV1 measurement from a pulmonary function test. The management of BOS has been disappointing. In general, BOS is treated by intensifying the immunosuppressive regimen. Despite treatment, most patients continue to show progressive decline in lung function resulting in worsening functional status, quality of life, and ultimately graft failure and death.

Extracorporeal Photopheresis (ECP) has been used as a salvage treatment for progressive BOS with favorable clinical results in many cases showing patient improvement. On May 2, 2012, the Center for Medicare Services issued a decision memo statin the ECP is covered for Medicare beneficiaries for the treatment of BOS following lung allograft transplantation only wehn the procedure is provided under a clinical research study. It is highly unlikely that providers that currently order ECP for their BOS patients who have already failed optimized immunosuppressive drug therapy would be willing to randomize half of their patients to continue on their failed drug therapy.What is not well understood at this time, however, is whether certain coexisting disease states or patient-related demographic, functional, treatment-related or diagnostic variables might prove to have predictive value in identifying subsets

Detailed Summary:

There is evidence to support that ECP benefits these patients, but we don't know how to predict which patients will benefit most. Patients will will be identified by physician investigators and co-investigators, and study staff, and through review of relevant administrative databases that are maintained for routine clinical care purposes (e.g. lung transplantation division database, pulmonary function laboratory database, etc.), subject to local IRB approval. Once eligibility is confirmed and the patient is provided informed consent, the patient will be assigned a unique case number created from the electronic data base. The patient demographics, co-morbidities, medical history including date of lung transplantation, underlying disease necessitating lung transplantation, vital signs, height , weight, and current medication regimen, maintenance immunosuppression and any changes in medication should be entered on the electronic case report forms. All FEV1 measurements captured within the 6 months prior to enrollment should be entered in the electronic case report forms.Certain source documents will be required and verified on all forms electronically submitted. Necessary source documents will be clearly requested on the electronic case report forms.

Patients should receive 24 ECP treatments over the 6-month period following enrollment, in accordance with the following schedule:

  • 8 to 10 treatments over the first 30 days following treatment initiation;
  • 8 to 10 treatments in the next 60 days (months 2 and 3);
  • 6 treatments in the next 90 days (months 4 through 6) at a rate of 2 treatments per month.

During ECP, blood is taken from the body through a standard venous cathete
Sponsor: Washington University School of Medicine

Current Primary Outcome: Change in the rate of FEV1 decline assessed by comparing the average rate of FEV1 decline over the 6 months prior to ECP against the average rate of FEV1 decline over the 6 months following initiation of ECP [ Time Frame: 1 year ]

The study will prospectively capture FEV1 through spirometry during the course of ECP therapy and out to one year in accordance with the following schedule: Days 0, 30, 60, 90, 120,150, 180, 240, 300 and 365. Spirometry from Day 0 through Day 120 may be performed within 7 days to accommodate patient/provider scheduling needs, and generally will coincide with a scheduled ECP treatment. Spirometry from Day 150 through Day 365 may be per formed within 14 days to meet patient/provider scheduling needs.


Original Primary Outcome: Same as current

Current Secondary Outcome: Average rate of FEV1 decline over the 12 months following initiation of ECP [ Time Frame: 12 months ]

The study will prospectively capture FEV1 through spirometry during the course of ECP therapy and out to one year in accordance with the following schedule: Days 0, 30, 60, 90, 120,150, 180, 240, 300 and 365. Spirometry from Day 0 through Day 120 may be performed within 7 days to accommodate patient/provider scheduling needs, and generally will coin cide with a scheduled ECP treatment. Spirometry from Day 150 through Day 365 may be per formed within 14 days to meet patient/provider scheduling needs.


Original Secondary Outcome: Same as current

Information By: Washington University School of Medicine

Dates:
Date Received: July 1, 2014
Date Started: January 2015
Date Completion: December 2018
Last Updated: November 22, 2016
Last Verified: November 2016