Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048789
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2002-11-07
Brief Title:
Extracorporeal Photopheresis to Treat Chronic Graft-Versus-Host Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Chronic Graft Versus Host Disease With Extracorporeal Photopheresis
Status:
COMPLETED
Status Verified Date:
2009-01-29
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the safety and effectiveness of extracorporeal photopheresis ECP for treating chronic graft-versus-host disease GvHD GvHD is a common complication of stem cell transplantation using donated stem cells It occurs when the donors T-lymphocytes a type of immune cell see the patients cells as foreign and mount an immune response to reject them The attack can cause skin rash mouth sores liver or lung inflammation lack of appetite and muscle stiffness Chronic GvHD can cause serious illness and even death from the long-term effects of immune dysfunction and from toxic effects of medications such as cyclosporine and prednisone used to treat it
ECP is an experimental treatment designed to stop the lymphocytes from attacking the body It involves collecting some of the cells that cause GvHD treating them with a combination of drug and light therapy and returning them to the body Sixty to 80 percent of patients with chronic GvHD improve with ECP treatment and some patients can stop treatment with prednisone or cyclosporine or reduce the drug dosages
Patients with chronic GvHD whose condition has not improved after a minimum 14-day course of cyclosporine and prednisone may be eligible for this study Patients must be able to travel to the NIH Clinical Center in Bethesda Maryland twice a week during the 3-month study period
Upon entering the study participants will have a baseline evaluation to measure the extent of GvHD This assessment includes blood tests eye and dental examinations skin biopsy for patients with skin involvement and CT scans and lung function tests to look for possible lung involvement Biopsies of the lung liver mouth or eye may be requested if needed to confirm GvHD in these tissues The skin will be photographed before starting ECP treatment and once a month during the treatment period Following baseline tests participants will undergo treatment and evaluations as follows
ECP Treatment
Patients will have blood drawn to collect lymphocytes causing GvHD This may be done with a special needle or catheter tube inserted into a vein or for patients who need or prefer it with a temporary central venous catheter similar to that used for the stem cell transplantation Patients will have three 2- to 3-hour treatments a week for the first week and two treatments a week after that for a total of 25 treatments over 3 months Patients who do not tolerate the treatment
ECP is an experimental treatment designed to stop the lymphocytes from attacking the body It involves collecting some of the cells that cause GvHD treating them with a combination of drug and light therapy and returning them to the body Sixty to 80 percent of patients with chronic GvHD improve with ECP treatment and some patients can stop treatment with prednisone or cyclosporine or reduce the drug dosages
Patients with chronic GvHD whose condition has not improved after a minimum 14-day course of cyclosporine and prednisone may be eligible for this study Patients must be able to travel to the NIH Clinical Center in Bethesda Maryland twice a week during the 3-month study period
Upon entering the study participants will have a baseline evaluation to measure the extent of GvHD This assessment includes blood tests eye and dental examinations skin biopsy for patients with skin involvement and CT scans and lung function tests to look for possible lung involvement Biopsies of the lung liver mouth or eye may be requested if needed to confirm GvHD in these tissues The skin will be photographed before starting ECP treatment and once a month during the treatment period Following baseline tests participants will undergo treatment and evaluations as follows
ECP Treatment
Patients will have blood drawn to collect lymphocytes causing GvHD This may be done with a special needle or catheter tube inserted into a vein or for patients who need or prefer it with a temporary central venous catheter similar to that used for the stem cell transplantation Patients will have three 2- to 3-hour treatments a week for the first week and two treatments a week after that for a total of 25 treatments over 3 months Patients who do not tolerate the treatment
Detailed Description:
This is a phase 2 study of extracorporeal photopheresis ECP for treatment of chronic graft versus host disease following allogeneic hematopoietic stem cell transplantation Extracorporeal exposure of human mononuclear cells to ultraviolet A radiation following photosensitization with 8-methoxypsoralen has proven to be an effective treatment for cutaneous T-cell lymphoma Small single institution studies have suggested efficacy in other T-cell mediated diseases such as solid organ rejection and graft versus host disease This a phase 2 study of ECP for treatment of chronic graft versus host disease Eligible patients must have objective evidence of chronic graft versus host disease that is refractory to conventional therapy or must have steroid-dependent disease that does not permit steroid dose reduction The primary objective of this study is to better define the safety efficacy and mechanism of action of ECP for treatment of patients with chronic graft versus host disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-I-0025 | None | None | None |