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

• Sponsor: University Hospital, Clermont-Ferrand (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00824954
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 42
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Graft Versus Host Disease	Procedure: ECP (performed on Themos UVAR-XTS or external UVA irradiator after cell collection by apheresis)	Phase 2

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
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Extracorporeal Photochemotherapy in Children and Young Adults With Refractory Acute Graft Versus Host Disease After Allogeneic Stem Cell Transplantation
• Study Start Date: Jun 1, 2009
• Anticipated Primary Completion Date: Jun 1, 2012
• Anticipated Study Completion Date: Dec 1, 2012

Outcome Measures

Primary Outcome Measures

1. GVHD grading [during weeks 2 to 10]

Secondary Outcome Measures

1. Overall survival Incidence of chronic GVHD [during weeks 2 to 10]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 30 Years
• Sexes Eligible for Study: 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Clermont-Ferrand	Clermont-Ferrand		France	63000

Sponsors and Collaborators

• University Hospital, Clermont-Ferrand

Investigators

• Principal Investigator: Etienne Merlin, University Hospital, Clermont-Ferrand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00824954
• Other Study ID Numbers: CHU-0043
• First Posted: Jan 19, 2009
• Last Update Posted: Jan 19, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: 0 to 30 years; Refractory Acute GVHD
• Additional relevant MeSH terms: Graft vs Host Disease

Study Results

No Results Posted as of Jan 19, 2011