Overview

Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)

Status:
Completed

Trial end date:
2015-03-01

Target enrollment:
0

Participant gender:
All

Summary

Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells. Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets a port to hook up to a machine. The machine removes the white blood cells, mixes them with a light-sensitive drug, shines light on it, and puts all the blood back in. This study will find out if patients respond better if they get ECP with methoxsalen, in addition to the pills normally used to treat cGVHD.

Phase:

Early Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Mallinckrodt

Collaborator:

Parexel

Treatments:

Cyclosporine
Cyclosporins
Methoxsalen
Prednisone
Tacrolimus

Criteria

Inclusion Criteria:

To be eligible for inclusion in this trial, the patient must have moderate to severe
chronic graft-versus-host disease [defined by the National Institutes of Health (NIH) 2015
Consensus Criteria] that started within 3 years after hematopoietic stem cell
transplantation (HSCT).

Exclusion Criteria:

- Is intolerant to corticosteroids or hypersensitive to methoxsalen

- Received certain treatments during time periods disallowed by protocol

- Has infections and/or requires treatment that (per protocol or in the opinion of the
investigator) might compromise:

1. safety and well-being of participant or offspring

2. safety of study staff

3. analysis of results