Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT06133192
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06133192
Study Brief:
Protocol Section:
NCT06133192