Steroids Versus ECP and Steroids as First-line Treatment of Grade II Acute GVHD

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · Nov 10, 2023

Keywords

ClinConnect Summary

This clinical trial is designed to compare two different treatments for Grade II acute graft-versus-host disease (GVHD), a condition that can occur after a stem cell transplant. Researchers want to see if a combination of steroids and a special treatment called extracorporeal photopheresis (ECP) works better than steroids alone as the first line of treatment. The main goal is to find out how many patients are free from treatment failure after six months, which means they are alive, their original blood disease hasn’t returned, they haven’t needed additional treatments for GVHD, and they haven’t started treatment for chronic GVHD.

To participate in this trial, you must be over 18 years old and have received a stem cell transplant. You should be experiencing Grade II acute GVHD that affects your skin, and you need to be able to start treatment within three days after being randomly assigned to a group. Participants will receive either the steroid treatment alone or the combination with ECP. It's important to note that this trial is not yet recruiting, but it will encompass all adults in the age range of 18 and older. If you think you may be eligible, it will be necessary to review the detailed criteria and discuss it with your healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • - 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.