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

Verified siteInvestigationalNo placebo
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What is this trial about?

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

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 1x10⁹ per liter and a platelet count (cells that help blood clot) of at least 20x10⁹ 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 trial?

3 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

Belumosudil – Belumosudil is a medication taken by mouth in tablet form that is currently being studied in clinical trials for treating a serious complication that can occur after bone marrow or stem cell transplants called graft-versus-host disease, specifically when it affects multiple organs at once and does not respond to steroid treatment. This drug works by blocking a specific enzyme called ROCK2, which helps reduce inflammation and prevents the immune system from attacking the body's own tissues. Belumosudil belongs to a class of medications known as kinase inhibitors, which are designed to target specific proteins involved in disease processes.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521940-39-00Protocol code1240 - BEAT-GVHDEstimated enrolment24 patientsSponsorMedical Center - University Of Freiburg

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