Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Male and Female Participants Aged 12 Years and Above With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy

Investigation of Oral Medication in Diverse Participants with Chronic Graft Versus Host Disease (cGVHD)

Recruiting
12 years or above
All
Phase 2
36 participants needed
3 Locations

Study Overview

The purpose of this study is to measure safety and efficacy of oral belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander male and female participants with cGVHD who have previously been treated with at least 2 prior lines of systemic therapy aged 12 years and above.

The duration of participants participation will be up to 4 weeks for screening, treatment until clinically significant progression of disease, and 4 weeks of safety follow-up, and then long-term follow-up every 12 weeks.1 Cycle = 28 days.

Study Details

Up to 4 weeks for screening, treatment until clinically significant progression of disease, 4 weeks of safety follow-up and then long-term follow-up every 12 weeks.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Graft Versus Host Disease
  • Age: 12 years or above
  • Gender: All

Inclusion Criteria:

  • Participants are included in the study if any of the following criteria apply:
  • Participant is Black or African American, or American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander by self-identification.
  • Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD.
  • Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening.
  • Have persistent cGVHD manifestations and systemic therapy is indicated.
  • Karnofsky (if aged ≥ 16 years) / Lansky (if aged < 16 years) Performance Score of ≥ 60.
  • At least 12 years of age; weight ≥ 40 kilograms (kg).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN).
  • Total bilirubin ≤ 1.5 x ULN.
  • Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • Participants are excluded from the study if any of the following criteria apply:
  • Participant has not been on a stable dose/regimen of systemic cGVHD treatment(s) for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and ECP are acceptable. Systemic investigational GVHD treatments are not permitted).
  • Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
  • Current treatment with ibrutinib or ruxolitinib. Prior treatment with ibrutinib or ruxolitinib is allowed with a washout of at least 28 days prior to enrollment.
  • History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease, or coronary artery disease).
  • Corrected QT interval using Fridericia's formula (QTc[F]) > 480 ms.
  • Forced expiratory volume (in the first second; FEV1) ≤ 39% The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

This study investigates the safety and effectiveness of an investigational medication in participants with chronic graft versus host disease (cGVHD). The study focuses on Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander participants who have already been treated with at least two prior lines of systemic therapy.

Participants will receive the investigational medication while their health is monitored. The study includes screening, treatment until significant disease progression, and follow-up assessments. Safety follow-ups will occur for four weeks, and long-term follow-ups will be conducted every 12 weeks.

  • Who can participate: Participants must be at least 12 years old and weigh at least 40 kilograms. They should identify as Black or African American, American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander. Participants must have received 2 to 5 previous lines of systemic therapy for cGVHD and have stable glucocorticoid therapy.
  • Study details: Participants will take an investigational medication and undergo regular health assessments. They must use double contraception methods if applicable and should not be pregnant or breastfeeding. Informed consent is required.
Updated on 18 Jun 2025. Study ID: NCT05567406

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