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

U

University Hospital, Clermont-Ferrand

Status and phase

Unknown
Phase 2

Conditions

Graft Versus Host Disease

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00824954
CHU-0043

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

Under 30 years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Patrick Lacarin

Data sourced from clinicaltrials.gov

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