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

Primary Purpose

Graft Versus Host Disease

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Graft Versus Host Disease focused on measuring 0 to 30 years, Refractory Acute GVHD

Eligibility Criteria

undefined - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

CHU Clermont-FerrandRecruiting

Outcomes

Primary Outcome Measures

GVHD grading

Secondary Outcome Measures

Overall survival Incidence of chronic GVHD

Full Information

NCT ID

NCT00824954

First Posted

December 18, 2008

Last Updated

January 18, 2011

Sponsor

University Hospital, Clermont-Ferrand

1. Study Identification

Unique Protocol Identification Number

NCT00824954

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Unknown status

Study Start Date

June 2009 (undefined)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Clermont-Ferrand

4. Oversight

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Graft Versus Host Disease

Keywords

0 to 30 years, Refractory Acute GVHD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

GVHD grading

Time Frame

during weeks 2 to 10

Secondary Outcome Measure Information:

Title

Overall survival Incidence of chronic GVHD

Time Frame

during weeks 2 to 10

10. Eligibility

Sex

All

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick Lacarin

Phone

04.73.75.11.95

placarin@chu-clermontferrand.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Etienne Merlin

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick Lacarin

Phone

0473751195

placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

Learn more about this trial

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

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