NCT00824954

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2011

Enrollment Period

3 years

First QC Date

December 18, 2008

Last Update Submit

January 18, 2011

Conditions

Graft Versus Host Disease

Keywords

0 to 30 yearsRefractory Acute GVHD

Outcome Measures

Primary Outcomes (1)

  • GVHD grading

    during weeks 2 to 10

Secondary Outcomes (1)

  • Overall survival Incidence of chronic GVHD

    during weeks 2 to 10

Interventions

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

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

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Eosinophil Cationic Protein

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

EndoribonucleasesRibonucleasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesEosinophil Granule ProteinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Etienne Merlin

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Lacarin

CONTACT

04.73.75.11.95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2008

First Posted

January 19, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

January 19, 2011

Record last verified: 2011-01

Locations

FR(1)