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BEAT-GVHD (Belumosudil for acute/chronic GVHD overlap syndrome)
EU CTIS ID: 2025-521940-39-00
What this study is testing
Primary objective is to perform a first evaluation of the efficacy of belumosudil in patients with moderate to severe steroid refractory-overlap syndrome (os) graft-versus-host-disease (GVHD) assessed by Overall Response Rate (ORR) at week 25 (Cycle 7 Day 1).
- 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
- Male and female patients aged ≥18 years
- Participant is willing and able to give informed consent for participation in the study
- Patient body weight ≥40kg.
- Patients have undergone alloSCT from any donor source (matched unrelated donor sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible.
- Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines.
- SR-osGVHD diagnosis: Patients with clinically diagnosed moderate to severe osGVHD according to NIH Consensus Criteria
You likely can't join if
- Patient has received more than one systemic treatment for cGVHD other than corticosteroids + calcineurin inhibitors (CNI) (prophylaxis or treatment).
- 10. Hepatic impairment with Child-Pugh B or C liver cirrhosis. AST or ALT 5x upper limit of normal (ULN) or higher or bilirubin 1.5x ULN or higher even if liver impairment is likely due to GVHD
- Impairment of gastrointestinal (GI) function (unrelated to GVHD) or GI disease (unrelated to GVHD) that may significantly alter the absorption of oral belumosudil (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- Any corticosteroid therapy for indications other than cGVHD at doses >1 mg/kg/day methylprednisolone or equivalent within 7 days before Cycle 1 Day 1.
- Patient is receiving and does not agree to stop herbal preparations/medications. These herbal medications include, but are not limited to, St. John’s Wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng. Patients must stop using herbal medications at least 7 days prior to first dose of study treatment.
- Known allergies, hypersensitivity, or intolerance of belumosudil or any of its excipients or similar compounds.
See the full eligibility criteria
Who can join
- Male and female patients aged ≥18 years
- Participant is willing and able to give informed consent for participation in the study
- Patient body weight ≥40kg.
- Patients have undergone alloSCT from any donor source (matched unrelated donor sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or cord blood. Recipients of non-myeloablative, myeloablative, and reduced intensity conditioning are eligible.
- Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines.
- SR-osGVHD diagnosis: Patients with clinically diagnosed moderate to severe osGVHD according to NIH Consensus Criteria
- Patients who have received systemic glucocorticoids for the treatment of chronic graft-versus-host disease for a duration of < 6 months prior to cycle 1 day 1 and have a confirmed diagnosis of steroid refractory osGVHD defined per 2014 NIH consensus criteria (Martin 2015) irrespective of the concomitant use of a CNI, as follows:•A lack of response or disease progression after administration of minimum prednisone 1 mg/kg/day for ≥1 week (or equivalent) or•Disease persistence without improvement despite continued treatment with prednisone at >0.5 mg/kg/day or 1 mg/kg/every other day for ≥4 weeks (or equivalent) or•Increase to prednisone dose to >0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent)
- Evident myeloid and platelet engraftment: absolute neutrophil count (ANC)>1x109/L and platelet count >20x109/L
- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of hCG) within 24 hours prior to the start of study drug.
- Able to swallow tablets
- Eastern Co-operative Oncology Group (ECOG) performance status 0, 1, or 2
What rules you out
- Patient has received more than one systemic treatment for cGVHD other than corticosteroids + calcineurin inhibitors (CNI) (prophylaxis or treatment).
- 10. Hepatic impairment with Child-Pugh B or C liver cirrhosis. AST or ALT 5x upper limit of normal (ULN) or higher or bilirubin 1.5x ULN or higher even if liver impairment is likely due to GVHD
- Impairment of gastrointestinal (GI) function (unrelated to GVHD) or GI disease (unrelated to GVHD) that may significantly alter the absorption of oral belumosudil (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- Any corticosteroid therapy for indications other than cGVHD at doses >1 mg/kg/day methylprednisolone or equivalent within 7 days before Cycle 1 Day 1.
- Patient is receiving and does not agree to stop herbal preparations/medications. These herbal medications include, but are not limited to, St. John’s Wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng. Patients must stop using herbal medications at least 7 days prior to first dose of study treatment.
- Known allergies, hypersensitivity, or intolerance of belumosudil or any of its excipients or similar compounds.
- Sexually active men and female patients of child-bearing potential who are not willing to use highly effective methods of contraception during the trial and at least 1 week after the last belumosudil
- Pregnancy and lactation
- Failed prior allogeneic hematopoietic stem cell transplantation (alloSCT) within the past 6 months.
- Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
- Evidence of active viral infection (confirmed by peripheral blood viral load) including CMV, EBV, HBV, or HCV. Patients with pre-transplant positive serology results indicative of high risk for viral reactivation must have negative viral load results within 28 days prior toCycle 1 Day 1. Patients whose immune status is unknown or uncertain (e.g. serologies not obtained prior to transplant) must have viral load results confirming no evidence of active viral infection within 28 days prior toCycle 1 day 1.
- Presence of relapsed primary malignancy, or who have been treated for relapse after the alloSCT was performed, or who may require rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse.
- Active treatment in a clinical study of any investigational agent within 30 days prior to Cycle 1 Day1, or within 5 half-lives of the study treatment, whichever is longer
- SR-osGVHD occurring after a non-scheduled donor lymphocyte infusion (DLI) administered for pre-emptive treatment of malignancy recurrence. Patients who have received a scheduled DLI as part of their transplant procedure (up to day 120) and not for management of malignancy relapse are eligible.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration and contraindications of study drug/study procedure and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
- Presence of severely impaired renal function defined by serum creatinine > 2 mg/dL (>176.8μmol/L), renal dialysis requirement, or have estimated creatinine clearance <30 ml/min measured or calculated by Cockroft Gault equation (confirmed within 48 hours prior to study treatment start).
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, 65+ 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.