Status:
NOT_YET_RECRUITING
Steroids Versus ECP and Steroids as First-line Treatment of Grade II Acute GVHD
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Graft Vs Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to compare as a first line of grade II skin acute GVHD sconventional treatment with steroids alone to a combination of steroids and extracoporeal photopheresis (ECP)...
Detailed Description
A multi-center randomized phase II study comparing corticosteroids alone (standard of care) versus corticosteroids and extracorporeal photopheresis as first-line treatment of Grade II acute graft-vers...
Eligibility Criteria
Inclusion
- Age \> 18 years,
- allogeneic hematopoietic stem cell transplantation received (from any type of graft and donor) after malignant or non malignant disease
- patient suffering from Grade II acute GVHD with skin +/- high GI involvement (stage 2-3 skin + upper gastrointestinal tract or skin stage 3) in the 3 months following stem cell transplantation
- patient requiring first line treatment for acute GVHD
- patient able to start PCE therapy in the 3 days after randomization
- validation of the presence of a peripheral or central venous access (its type should be conform to the recommendations described in the Therakos Cellex operator manual), allowing to perform PCE sessions weekly during 3 months. In the absence of appropriate preexisting central line at inclusion, peripheral access will be preferred.
- leukocytes \> 1.5 G/l, platelets \> 30 G/l, hematocrit \> 27% (blood transfusion are permitted), based on the last available blood testing results,
- patient with French Health Insurance,
- patient informed about the clinical trial content and organization,
- informed consent form signed.
Exclusion
- \- Grade 1 acute GVHD,
- acute GVH grade \> II or acute GVH with lower gastrointestinal tract or with liver involvement,
- relapse of the hematologic disease at time of acute GVHD,
- uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, CMV reactivation with increasing CMV viral load,
- HIV positivity or replicative HBV or HCV infection (based on pre-transplant assessment),
- patient with allergy or contraindications to UVADEX, extracorporeal photopheresis, steroids, or posaconazole (see details in the study protocol),
- woman of childbearing age without efficient contraceptive method, pregnancy or breast feeding woman,
- patient with history of profound venous thrombosis in the last 5 years,
- patient included in another acute GVHD prospective clinical trial.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06133192
Start Date
January 1 2024
End Date
January 1 2026
Last Update
November 15 2023
Active Locations (1)
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1
CHRU de Nancy
Vandœuvre-lès-Nancy, France, 54511