A Study of Belumosudil for Patients with Steroid-Resistant Overlap Syndrome Graft-versus-Host Disease

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What is this study about?

This study involves patients with a condition called steroid-refractory overlap syndrome Graft-versus-Host-Disease, which can occur after a stem cell transplant when the donated immune cells attack the recipient’s body. This condition is called an overlap syndrome because it has features of both the early and late forms of this disease. When the disease does not respond well to treatment with steroids, it is considered steroid-refractory. The treatment being studied is a medication called belumosudil, which is given as a film-coated tablet taken by mouth. Patients will receive up to 400 milligrams of the medication daily for a treatment period that can last up to 52 weeks.

The purpose of this study is to evaluate how well belumosudil works in patients with moderate to severe steroid-refractory overlap syndrome Graft-versus-Host-Disease by measuring the overall response rate at week 25 of treatment. During the study, patients will take belumosudil tablets daily while doctors monitor their condition through regular visits. The study will track whether the disease improves, stays the same, or gets worse, and whether patients need additional treatments. Doctors will also look at how symptoms change over time, particularly by measuring improvements in symptom scores and whether patients can reduce or stop taking steroids.

Throughout the study, doctors will monitor various aspects of patient health and disease response. This includes checking how different organs affected by the disease respond to treatment, measuring changes in immune cells in the blood, and assessing overall survival and quality of life. The study will also track any side effects or unwanted reactions that patients may experience while taking belumosudil. Blood tests and physical examinations will be performed regularly to evaluate how the treatment is working and to ensure patient safety during the entire treatment period.

1 Treatment initiation and first cycle

Upon joining the study, treatment with belumosudil will begin. This medication is provided as a film-coated tablet taken by mouth.

The treatment is organized in cycles. Each cycle consists of a specific treatment period during which the medication is taken regularly.

During this initial phase, baseline assessments will be performed to establish starting measurements for comparison with later results.

2 Ongoing treatment cycles 2 through 6

Treatment with belumosudil tablets continues through multiple cycles.

The medication is taken orally on a regular schedule as prescribed.

Throughout these cycles, monitoring of the condition and response to treatment occurs at scheduled intervals.

3 Week 25 assessment at cycle 7 day 1

At week 25, which corresponds to the first day of cycle 7, a comprehensive evaluation takes place.

The response to treatment is assessed at this time point. Response is measured by improvement in the condition compared to the baseline assessment.

The evaluation examines whether there has been a complete response, partial response, or no response to the treatment.

Changes in symptom scores are measured, looking for at least a 7-point reduction from the starting level.

The dosage of steroids (corticosteroid medications) is reviewed to determine if it has been reduced by at least 50 percent or discontinued completely.

4 Continued treatment and monitoring

Treatment with belumosudil continues beyond week 25.

Regular assessments continue at scheduled visits to monitor the ongoing response to treatment.

Blood samples are collected at various time points to analyze immune cells, including different types of white blood cells that are part of the immune system.

Quality of life is assessed using a standardized questionnaire at designated visits.

5 Treatment completion and follow-up

Treatment continues until completion of the planned duration or until the treating physician determines a change is necessary.

Any side effects or adverse events are monitored throughout the entire treatment period and for 30 days after the last dose of belumosudil.

Long-term outcomes are tracked, including survival, disease progression, and any recurrence of the underlying condition that led to the transplant.

Who Can Join the Study?

You must be 18 years of age or older
You must be willing and able to provide informed consent, which means agreeing to participate in the study after understanding what it involves
Your body weight must be at least 40 kilograms (about 88 pounds)
You must have received an allogeneic stem cell transplant, which is a procedure where you received blood-forming stem cells from a donor. The donor can be a matched unrelated person, a sibling, or a partially matched family member. The stem cells may have come from bone marrow, blood, or umbilical cord blood
You must have a diagnosis of moderate to severe overlap syndrome graft-versus-host disease, which is a condition where the donated cells attack your body, affecting multiple organs at the same time
Your condition must be steroid-refractory, meaning it has not responded adequately to steroid treatment. This is confirmed if your disease did not improve after taking a steroid medication called prednisone at a specific dose for at least one week, or if your disease continued without improvement despite taking prednisone for at least four weeks, or if your steroid dose had to be increased after two failed attempts to reduce it
You must have been receiving systemic glucocorticoids (steroid medications taken by mouth or injection that affect your whole body) for treating your condition for less than 6 months before starting the study treatment
Your bone marrow must be producing blood cells properly, shown by having an absolute neutrophil count (a type of white blood cell that fights infection) of at least 1×10⁹ per liter and a platelet count (cells that help blood clot) of at least 20×10⁹ per liter
If you are a woman who can become pregnant, you must have a negative pregnancy test within 24 hours before starting the study medication
You must be able to swallow tablets
Your ECOG performance status must be 0, 1, or 2. This is a scale that measures how well you can perform daily activities, where 0 means you are fully active, 1 means you have some restrictions on physical activity, and 2 means you can care for yourself but cannot work

Who Cannot Join the Study?

The study does not list specific exclusion criteria in the provided information, which means the detailed reasons why patients cannot participate are not available in this data
Generally, clinical trials may exclude patients based on factors such as other serious medical conditions, certain medications being taken, or laboratory test results that fall outside acceptable ranges
If you have questions about whether you can participate, the study team would need to review your complete medical history against their full list of criteria

Where you can join this trial?

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Other Sites

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

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.11.2025

Trial locations

Investigated drugs:

Belumosudil Mesilate

Belumosudil is a medication being tested in this trial to treat a condition called graft-versus-host disease that occurs after a stem cell transplant. This medicine works by blocking certain proteins in the body that contribute to inflammation and immune system problems. It is specifically being studied for patients whose condition has not improved with steroid treatment.

Investigated diseases:

Chronic graft versus host disease

Graft-versus-Host Disease – Graft-versus-Host Disease is a medical condition that occurs after a stem cell or bone marrow transplant from a donor. In this condition, the donated immune cells recognize the patient’s body tissues as foreign and begin to attack them. The disease can affect various organs and tissues, including the skin, liver, digestive system, and mucous membranes. It typically develops when there is a mismatch between the donor’s and recipient’s tissue types. The condition can present in acute or chronic forms, depending on when symptoms appear after transplantation. When the disease affects multiple organ systems simultaneously with overlapping features, it is referred to as overlap syndrome.

Trial ID:

2025-521940-39-00

Protocol code:

1240 – BEAT-GVHD

Trial Phase:

Therapeutic exploratory (Phase II)

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A Study of Belumosudil for Patients with Steroid-Resistant Overlap Syndrome Graft-versus-Host Disease

What is this study about?

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