Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00824954
NCT00824954UnknownPhase 2

Evaluation of Extracorporeal Photochemotherapy in Children and Young Adults With Refractory Acute Graft Versus Host Disease After Allogeneic Stem Cell Transplantation

University Hospital, Clermont-Ferrand2 sites in 1 country30 target enrollmentStarted: June 1, 2009Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 2
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
GVHD grading
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Purpose : to evaluate the efficacy of ECP in children with refractory acute GVHD This study addresses patients with persistent GVHD after steroid and/or monoclonal antibody therapy

Detailed Description

One arm. Six sessions in two weeks. Classification in complete response (resolution of all signs of GVHD), partial response (improvement of at least one grade) or absence of response (Glucksberg criteria). Tapering depending on patient condition during weeks 2 to 10. Final evaluation at week 10. Steroid therapy tapering at the discretion of the investigator.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 30 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •0 to 30 years
  • •Acute GVHD refractory to steroids (disease progression after 2 days or absence of response after 4 days) and/or second line therapy (absence of response after 8 days)
  • •patient consent and/or parent consent

Exclusion Criteria

  • •less of 10 kgs BW
  • •clinical or biological state precluding the apheresis
  • •previous GVHD therapy with anti-lymphocyte serum (excepted in the conditioning regimen)

Outcomes

Primary Outcomes

GVHD grading

Time Frame: during weeks 2 to 10

Secondary Outcomes

  • Overall survival Incidence of chronic GVHD(during weeks 2 to 10)

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Sponsor Class
Other

Study Sites (2)

Loading locations...

Similar Trials

Terminated
Not Applicable
Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host DiseaseGraft Versus Host DiseaseExtracorporeal Photopheresis
NCT03438643University Hospital, Lille8
Completed
Phase 2
Phase II Pilot Study of Extracorporeal Phototherapy for Epidermolysis Bullosa AcquisitaEpidermolysis Bullosa Acquisita
NCT00004359National Center for Research Resources (NCRR)10
Completed
Phase 2
Extracorporeal Photopheresis to Treat Chronic Graft-Versus-Host DiseaseGraft vs Host Disease
NCT00048789National Institute of Allergy and Infectious Diseases (NIAID)25
Completed
Not Applicable
Photopheresis in GvHD After Hematopoietic Transplantation: Characteristics of the Procedure and of the Cell ProductGraft Vs Host DiseaseExtracorporeal Photopheresis
NCT05718674Fondazione Policlinico Universitario Agostino Gemelli IRCCS27
Completed
Early Phase 1
Test Extracorporeal Photopheresis (ECP) Treatment Before/After Allogeneic Bone Marrow Transplant (BMT) or Peripheral Blood Stem Cell (PBSC) Transplant to Prevent Graft Versus Host DiseaseStem Cell Leukemia of Unclear LineageGraft Versus Host Disease
NCT01174940University of Kansas Medical Center22