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Study Comparing Methylprednisolone and Methoxsalen for Treating Grade II Acute Graft-Versus-Host Disease in Adult Stem Cell Transplant Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Grade II acute graft-versus-host disease (GVHD), which can occur after a patient receives a stem cell transplant from a donor. This condition often affects the skin and may also involve the upper part of the digestive system. The study aims to compare two different treatment approaches for this condition. One group of patients will receive treatment with corticosteroids alone, while the other group will receive a combination of corticosteroids and a procedure called extracorporeal photopheresis (ECP). ECP is a process where blood is treated outside the body to help manage the disease.

The trial will involve the use of several medications. SOLUMEDROL, which contains the active ingredient methylprednisolone hemisuccinate, and CORTANCYL, which contains prednisone, are both corticosteroids used in the study. Additionally, Uvadex, containing methoxsalen, is used in conjunction with the ECP procedure. Another medication, Noxafil, which contains posaconazole, is also part of the study. The purpose of the study is to determine which treatment approach is more effective in preventing treatment failure, which means the disease does not worsen or require additional treatment, over a period of six months.

Participants in the study will be randomly assigned to one of the two treatment groups. The study will last for several months, during which patients will receive their assigned treatment and be monitored for any changes in their condition. The goal is to see how well each treatment works in managing the symptoms of acute GVHD and to assess the overall health and quality of life of the participants. The study will also track any side effects or complications that may arise during the treatment period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving only corticosteroids and the other receiving corticosteroids plus extracorporeal photopheresis (ECP).

  2. Step 2

    Initial treatment phase

    The patient will begin treatment with corticosteroids. The specific medication used is prednisone, administered orally in the form of CORTANCYL 20 mg tablets.

    If assigned to the experimental group, the patient will also receive ECP, which involves the use of methoxsalen in the form of Uvadex 20 micrograms/mL solution for blood fraction modification.

  3. Step 3

    Treatment administration

    For the experimental group, ECP sessions will be conducted weekly for a duration of 3 months. This requires a suitable venous access, either peripheral or central, as per the guidelines.

    The patient will continue taking prednisone as prescribed, with the dosage adjusted based on the response to treatment.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient's health will be monitored regularly. This includes checking for any signs of treatment failure, such as the need for additional treatment or the occurrence of chronic graft-versus-host disease (GVHD).

    Blood tests will be conducted to monitor immune system recovery and to check for any infections or complications.

  5. Step 5

    Evaluation at 6 months

    At 6 months, the patient's progress will be evaluated to determine the effectiveness of the treatment. This includes assessing the absence of treatment failure, which is defined by being alive, not having a relapse of the original disease, not requiring new treatment for acute GVHD, and not starting systemic treatment for chronic GVHD.

  6. Step 6

    Long-term follow-up

    The study will continue to monitor the patient for up to 12 months to assess long-term outcomes such as overall survival, disease-free survival, and quality of life.

    Regular assessments will be conducted to evaluate the incidence of infections, thromboembolic complications, and any signs of chronic GVHD.

Who can join the trial?

11 criteria

  • Must be over 18 years old.
  • Must have received full information about the clinical trial and signed a consent form agreeing to participate.
  • Must have undergone a clinical screening that is suitable for the trial.
  • Must have received an allogeneic hematopoietic stem cell transplantation, which means a stem cell transplant from a donor, after having a disease that could be cancerous or not.
  • Must have Grade II acute GVHD, which is a condition where the transplanted cells attack the body, affecting the skin and possibly the upper part of the digestive system, within 3 months after the transplant.
  • Must need first-line treatment for acute GVHD.
  • Must be able to start ECP therapy, a type of treatment, within 3 days after being randomly assigned to a treatment group.
  • Must have a suitable venous access, which is a way to access the veins, to allow weekly treatment sessions for 3 months. If there is no existing central line, a peripheral access will be preferred.
  • Must have a leukocyte count (white blood cells) greater than 1.5 G/L based on the latest blood test results.
  • Must have a platelet count greater than 30 G/L and a hematocrit level greater than 27% (blood transfusions are allowed) based on the latest blood test results.
  • Must be affiliated with a social security scheme or be a beneficiary of such a scheme.

Who cannot join the trial?

5 criteria

  • Patients who are not adults cannot participate. This means only individuals 18 years or older are eligible.
  • Patients who are not receiving an allogeneic hematopoietic stem cell transplantation cannot participate. This is a type of transplant where a person receives blood-forming stem cells from a donor.
  • Patients who do not have a Grade II acute GVH cannot participate. GVH stands for Graft Versus Host disease, which is a condition that can occur after a transplant. Grade II indicates a moderate level of this condition.
  • Patients who do not have skin involvement or upper gastrointestinal involvement cannot participate. This means the condition must affect the skin or the upper part of the digestive system.
  • Patients who are not treated in the specific transplant centers contributing to this trial cannot participate. This means the study is limited to certain hospitals or clinics.
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Investigated drugs

  • Corticosteroids

    are medications used to reduce inflammation in the body. In this clinical trial, they are used as a standard treatment for patients with Grade II acute graft-versus-host disease (GVHD) with skin involvement. Corticosteroids help to suppress the immune system and decrease the symptoms of GVHD.

  • Extracorporeal Photopheresis (ECP)

    is a therapy that involves taking a small amount of blood from the patient, treating it with a special medication, and then exposing it to ultraviolet light before returning it to the patient's body. This process helps to modify the immune system's response and is being tested in combination with corticosteroids to see if it improves outcomes for patients with acute GVHD.

What is already known about the treatment

  • Corticosteroids

    Corticosteroids are typically administered orally or intravenously, depending on the severity of the condition being treated. They are well-established in medical practice and literature, commonly used to reduce inflammation and suppress the immune system. In this trial, they are used to treat Grade II acute graft-versus-host disease (GVHD) with skin involvement following allogeneic stem cell transplantation. At the molecular level, corticosteroids work by binding to glucocorticoid receptors, leading to the suppression of pro-inflammatory genes and the activation of anti-inflammatory genes. They are classified as anti-inflammatory and immunosuppressive agents.

  • Extracorporeal Photopheresis (ECP)

    ECP is a procedure that involves the removal of blood, treatment with a photosensitizing agent, exposure to ultraviolet light, and reinfusion of the treated blood. It is an experimental treatment in this trial, used alongside corticosteroids for Grade II acute GVHD. ECP is thought to modulate the immune response by inducing apoptosis in pathogenic T-cells and promoting regulatory T-cell activity. It is classified as an immunomodulatory therapy.

Investigated diseases

Acute Graft-versus-Host Disease (GVHD) – This condition occurs when donor immune cells attack the recipient's body after an allogeneic hematopoietic stem cell transplantation. It typically affects the skin, liver, and gastrointestinal tract. In its early stages, patients may experience skin rashes, nausea, vomiting, diarrhea, and liver dysfunction. The disease is classified into grades based on severity, with Grade II involving moderate symptoms. Progression can lead to more severe organ involvement if not managed. The condition is a common complication in transplant recipients and requires careful monitoring.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508614-41-00Protocol code2023-0038Estimated enrolment124 patientsSponsorCHRU De Nancy

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