to evaluate the safety and efficacy of ECP as adjunct first-line therapy in patients with newly diagnosed chronic GVHD of the liver or lungs
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
GVHD response of the liver or lungs defined as response of liver or lung
manifestations to first-line immunosuppressive treatment
Secondary outcome
Transplant-related mortality
Relapse-free survival
Overall survival
Time to complete resolution of chronic GVHD to first-line immunosuppressive
therapy
Time to discontinuation of immunosuppressive treatment
Duration of response to first-line immunosuppressive therapy
Percent of patients in need of secondary treatment for chronic GVHD
Response to secondary treatment for chronic GVHD
Incidence of bacterial infections
Incidence of viral infections
Incidence of fungal infections
Side effects of ECP
Background summary
Chronic GVHD is the major cause of nonrelapse mortality in patients surviving
more than 2 years after allogeneic HSCT, and increasing severity of chronic
GVHD is associated with higher nonrelapse mortality rates. Infection from a
broad array of pathogens is the major cause of death, followed by progressive
organ failure from chronic GVHD involvement and/or GVHD treatment. During the
past 30 years survival of patients with chronic GVHD has not improved. Thus,
new therapeutic approaches to improve treatment response of patients with
chronic GVHD are urgently needed.
Study objective
to evaluate the safety and efficacy of ECP as adjunct first-line therapy in
patients with newly diagnosed chronic GVHD of the liver or lungs
Study design
This is a phase II study to evaluate the safety and efficacy of ECP as adjunct
first-line therapy in patients with newly diagnosed chronic GVHD of the liver
or lungs. Patients must be in need of systemic immunosuppressive therapy
defined as chronic GVHD involving three or more organs or with a score of 2 or
greater in any single organ
Intervention
extracorporeal photopheresis
Study burden and risks
ECP may cause hypotension and allergic reactions
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Presence of at least one diagnostic clinical sign of chronic GVHD or an appropriate constellation of distinctive signs confirmed by biopsy or other relevant diagnostic tests;Presence of liver manifestation of chronic GVHD after allogeneic HSCT;Presence of lung manifestation of chronic GVHD after allogeneic HSCT (bronchiolitis obliterans either confirmed by lung biopsy or diagnosed via pulmonary function and radiology testing);Indication for systemic immunosuppressive therapy defined as chronic GVHD that involves three or more organs or with a score of 2 or greater in any single organ.
Exclusion criteria
Patients with acute GVHD;Hypersensitivity or allergy to 8-methoxypsoralen;Hypersensitivity or allergy to both heparin and citrate products;Use of immunosuppressive medication other than CSA, FK506 and corticosteroids
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2005-004202-87-NL |
| CCMO | NL18842.029.07 |