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Clinical Trials/EUCTR2017-005162-22-FR
EUCTR2017-005162-22-FR
Active, not recruiting
Phase 1

A multi-center randomized phase II study comparing corticosteroids alone versus corticosteroids and extracorporal photopheresis (ECP) as first-line treatment of standard risk Grade II acute graft-versus-host disease after allogeneic stem cell transplantation - ECP-aGVHD

CHRU de Nancy0 sites78 target enrollmentFebruary 28, 2018
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ConditionsStandard II acute graft-versus-host disease following allogeneic stem cell transplantationTherapeutic area: Diseases [C] - Immune System Diseases [C20]
DrugsUVADEX

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Standard II acute graft-versus-host disease following allogeneic stem cell transplantation
Sponsor
CHRU de Nancy
Enrollment
78
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 28, 2018
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CHRU de Nancy

Eligibility Criteria

Inclusion Criteria

  • •\-Age \= 18 years ;
  • •\- Having received an allogeneic stem cell transplantation for any malignant or non\-malignant hemopathy and whatever the type of donor and graft.
  • •\-with grade II acute GVHD with skin involvement (stage 1\-3 skin \+/\- stage 1 gastro intestinal) in the 3 months following the allogeneic stem cell transplantation;
  • •\- acute GVHD in the first line treatment
  • •\-validation of the presence of peripheral or central venous access allowing to perform 2 ECP per week during 3 months;
  • •\- Leucocytes \> 1\.5 G/L
  • •\- Platelets \> 30 G/L, Haematocrite \> 27% (allowed transfusions)
  • •\-Patient affiliated to a French Sécurité Social regimen
  • •\-information consent form signed.
  • •Are the trial subjects under 18? no

Exclusion Criteria

  • •\- acute GVHD of grade I
  • •\- acute GVHD of grade \> II (Gastro intestinal stage \> 1 or hepatic involvement) ;
  • •\- progressive hematologic disease at inclusion
  • •\-uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, increasing CMV viral load.
  • •\-HIV positivity or replicative HBV or HCV infection ;
  • •\- Contraindications for UVADEX / photopheresis / stéroids
  • •\-Pregnancy ;
  • •\- Women of child bearing potentiel not using contaception

Outcomes

Primary Outcomes

Not specified

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