Extracorporeal Photopheresis in Children and Young Adults With Refractory Acute Graft Versus Host Disease

Graft Versus Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00824954
• Other study ID #: CHU-0043
• Status: Recruiting
• Phase: Phase 2
• First received: December 18, 2008
• Last updated: January 18, 2011
• Start date: June 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick Lacarin
• Phone: 04.73.75.11.95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Procedure:
• ECP (performed on Themos UVAR-XTS or external UVA irradiator after cell collection by apheresis)
ECP (performed on Thermos UVAR-XTS or external UVA irradiator after cell collection by apheresis)

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GVHD grading		during weeks 2 to 10	Yes
Secondary	Overall survival Incidence of chronic GVHD		during weeks 2 to 10	Yes