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

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

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)

The primary end point will compare Freedom from treatment failure at 6 months from randomization as defined by meeting all the following 4 conditions:

• to be alive

• without relapse of the hematological disease

• without having required a new line of treatment for acute GVHD

• without initiating a systemic treatment for chronic GVHD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Hospital, Nancy, France

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.