A multi-center randomized phase II study comparing corticosteroids alone versus corticosteroids and extracorporeal photopheresis as first-line treatment of Grade II acute graft-versus-host disease with skin involvement occuring after allogeneic stem cell transplantation - COPAVEHDI - 2023-0038

CHRU De Nancy0 sites78 target enrollmentNovember 20, 2023

ConditionsThe study will be proposed to all adult patients receiving an allogeneic hematopopietic stem cell transplantation and presenting a Grade II acute GVH with skin +/- upper gastrointestinal involvement, in transplant centers contributing to this trial (departments of hematology).Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: The study will be proposed to all adult patients receiving an allogeneic hematopopietic stem cell transplantation and presenting a Grade II acute GVH with skin +/- upper gastrointestinal involvement, in transplant centers contributing to this trial (departments of hematology).
Sponsor: CHRU De Nancy
Enrollment: 78
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 20, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

CHRU De Nancy

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years, An individual who has received full information about how the clinical trial will be conducted and has signed an informed consent form, An individual who has undergone clinical screening adapted to the clinical trial,, 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 \+/\- upper Gastrointestinal tract involvement (stage 2\-3 skin \+ stage 1 upper gastrointestinal tract or isolated skin stage 3\) in the 3 months following stem cell transplantation, patient requiring first line therapy to treat acute GVHD,, patient able to start ECP 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, Annex 3\), 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 based on the last available blood testing results,, Platelets \> 30 G/L, hematocrit \> 27% (blood transfusion are permitted), based on the last available blood testing results,, An individual affiliated to a social security scheme or beneficiary of such a scheme

Exclusion Criteria

•Grade 1 acute GVHD,, Patient with contraindications to posaconazole (NOXAFIL®): 1/Hypersensitivity to active ingredient or excipients,2/Ongoing treatment with ergot alkaloids, 3/Ongoing treatment with one CYP3A4 substrate which could lead to increased plasma concentration of these drugs, and so can result in QTc interval prolongation and rare cases of Torsade de Pointe (terfenadine, astemizole, cisapride, pimozide, halofantrin, quinidine), 4/Ongoing treatment with inhibitors of the HMG\-CoA reductase (simvastatin, lovastatin, atorvastatin) due to greater risk of rhabdomyolysis, 5/Ongoing or scheduled treatment with venetoclax, Ongoing or scheduled treatment on short\-term perspective with vinca\-alkaloids, Patients with medical history corresponding to contra\-indications to photopheresis:1/ aphakia, 2/photosensitive disease (e.g., porphyria, systemic lupus erythematosus, albinism), 3/cardiac insufficiency, 4/previous splenectomy, 5/coagulation abnormalities, 6/heparin\-induced thrombocytopenia, 7/uncontrolled digestive bleeding, Patients with contra\-indication to steroids:1/Allergy to prednisone or methylprednisolone, 2/Uncontrolled psychotic disease, patient with previous deep vein thrombosis in the last 5 years,, Patient with ongoing psychiatric cares as described in act L.3212\-1 et L.3213\-1 of the French Public Health code:1/Individuals referred to in Articles 10, 31, 32, 33 and 34 of Regulation (EU) No 536/2014, 2/Minor (not emancipated), 3/Adult subject to a legal protection measure (such as guardianship, conservatorship), 4/Adult who is unable to give consent, Included in another prospective study of acute GVH treatment, Acute GVHD grade \> II or acute GVH with lower tract gastrointestinal tract or with liver involvement,, Hematologic disease relapse 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),, Pregnant or breast feeding female, Women of childbearing age without effective contraception, Patient with allergy or contraindications to UVADEX : 1/ Known 8 MOP allergy 2/ Melanoma, basal cell, or squamous cell skin carcinoma, 3/ Phenytoin treatment