Study on Ruxolitinib and Methoxsalen for Patients with Steroid-Refractory Chronic Graft-versus-Host Disease

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What is this study about?

This clinical trial is focused on studying a condition known as steroid-refractory chronic Graft-versus-Host Disease (SR-cGvHD). This is a condition that can occur after a stem cell or bone marrow transplant, where the donated cells attack the recipient’s body. The study will explore the effects of two treatments used together: ruxolitinib, a medication taken as a tablet, and a procedure called extracorporeal photopheresis (ECP). ECP is a process where blood is treated outside the body to help manage the disease.

The purpose of the study is to evaluate the safety and effectiveness of combining these treatments for patients with SR-cGvHD. Participants will receive both ruxolitinib and ECP over a period of time, and their response to the treatment will be monitored. The study will assess how well the combination works in reducing the symptoms of SR-cGvHD and improving the overall health of the participants.

Throughout the study, participants will have regular visits to track their progress and any changes in their condition. The study aims to provide valuable information on whether this combined treatment approach can offer a new option for managing SR-cGvHD, especially for those who have not responded well to standard steroid treatments.

1 initiation of treatment

Upon joining the trial, the treatment begins with the administration of two medications: ruxolitinib and extracorporeal photopheresis (ECP).

Ruxolitinib is provided in the form of Jakavi 10 mg tablets and is taken orally. The specific dosage and frequency will be determined by the healthcare provider based on individual needs.

Extracorporeal photopheresis involves the use of UVADEX 20 microgram/ml solution for blood fraction modification. This process is extracorporeal, meaning it occurs outside the body.

2 treatment cycles

The treatment is organized into cycles. Each cycle lasts for a specific period, and the overall response is evaluated at the end of each cycle.

The primary evaluation of the treatment’s effectiveness occurs at week 25, which corresponds to Cycle 7 Day 1.

3 evaluation of response

The main goal is to assess the Overall Response Rate (ORR) at the week 25 visit. This involves determining the proportion of patients who show a complete or partial response to the treatment.

The response is measured relative to the organ score at the baseline assessment.

4 secondary assessments

Additional evaluations include failure-free survival, which measures the time until disease recurrence, the need for new systemic treatment, or death.

Other assessments include changes in symptom scores, overall survival, and the best overall response at any time point during the trial.

5 end of trial

The trial is expected to conclude by March 31, 2028.

Throughout the trial, regular monitoring and assessments will be conducted to ensure safety and measure the effectiveness of the treatment.

Who Can Join the Study?

Male and female patients who are 18 years or older.
Patients who have had a stem cell transplant from any donor source, using bone marrow, peripheral blood stem cells, or cord blood. This includes different types of conditioning treatments before the transplant.
Patients must have signed a written consent form approved by the appropriate regulatory and institutional guidelines.
Patients with a clinically diagnosed moderate to severe chronic Graft-versus-Host Disease (cGvHD), as defined by specific criteria. This includes certain scores for affected organs.
Patients who have been treated with systemic glucocorticoids (a type of steroid medication) for less than 6 months for chronic Graft-versus-Host Disease and meet specific criteria for being steroid-refractory. This means the disease did not respond to steroid treatment as expected.
Patients must have evident myeloid and platelet engraftment, meaning their blood cell counts have reached certain levels: absolute neutrophil count greater than 1×10⁹/L and platelet count greater than 25×10⁹/L.
Women who can have children must have a negative pregnancy test within 24 hours before starting the study medication.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, which is a scale used to assess how well a patient can perform daily activities.

Who Cannot Join the Study?

Patients who have not been diagnosed with steroid-refractory chronic Graft-versus-Host-Disease. This is a condition where the body reacts against a transplant, and it does not respond to steroid treatments.
Patients who are not within the specified age range for the trial. The trial is open to certain age groups only.
Patients who are part of a vulnerable population. This means groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Technische Universitaet Dresden	Dresden	Germany
Medical University Of Vienna	Vienna	Austria

Other Sites

Site Name	City	Country	Status
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	30.09.2024
Germany	Recruiting	30.09.2024

Trial locations

Investigated drugs:

Ruxolitinib is a medication used in this trial to help manage symptoms of chronic Graft-versus-Host Disease (cGvHD) that do not respond to steroids. It works by targeting specific pathways in the immune system to reduce inflammation and improve symptoms.

Extracorporeal Photopheresis (ECP) is a therapy that involves taking a small amount of blood from the patient, treating it with a special light, and then returning it to the body. This process helps to modify the immune system and is used in this trial to help control chronic Graft-versus-Host Disease (cGvHD) in patients who do not respond to steroids.

Investigated diseases:

Chronic graft versus host disease

Chronic Graft-versus-Host Disease – This condition occurs when donor cells attack the recipient’s body after a stem cell or bone marrow transplant. It can affect multiple organs, including the skin, liver, and digestive tract. Symptoms may include skin rashes, dry eyes, and mouth, as well as liver dysfunction. Over time, it can lead to scarring and damage to affected organs. The disease can vary in severity and may persist for months or years. It is considered chronic when symptoms last for more than 100 days post-transplant.

Trial ID:

2023-507754-33-00

Protocol code:

1154-RUX-ECP

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Ruxolitinib and Methoxsalen for Patients with Steroid-Refractory Chronic Graft-versus-Host Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?