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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
EU CTIS ID: 2023-508614-41-00
What this study is testing
To compare the percentage of patients who are not in treatment failure at 6 months from the start of treatment for acute GVH between the conventional treatment arm (corticosteroids alone) and the experimental arm (corticosteroids + ECP).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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,
You likely can't join if
- 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,
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.