Actively Recruiting
Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic Graft Versus Host Disease
Led by M.D. Anderson Cancer Center · Updated on 2026-02-18
8
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics of belumosudil tablets—both whole and crushed suspended in water—in adults with chronic graft-versus-host disease (cGVHD). The study aims to understand how the drug is processed in the body in these two forms, helping to inform treatment approaches for patients with this condition. This observational research is sponsored by the M.D. Anderson Cancer Center. The study involves monitoring patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) and suffer from cGVHD. Participants will receive belumosudil either as whole tablets or crushed tablets suspended in water. There is no mention of randomization or comparison groups as this is an observational study focusing on drug pharmacokinetics. Participants will be observed throughout the study, which lasts about one year on average. Researchers will assess safety and track any adverse events during this period. The study excludes pregnant women, those on certain medications, and individuals with cognitive impairments. Data collected will help understand how the drug behaves in the body and support future treatment decisions for cGVHD patients.
CONDITIONS
Brief Title
Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic GvHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects 18 years of age or older
- Have undergone allogeneic hematopoietic stem cell transplantation (HSCT)
You will not qualify if you...
- Receiving investigational GVHD treatment within 28 days of study entry
- Have active acute graft-versus-host disease (GVHD)
- Taking any medication known to be CYP3A4 inducers
- Pregnant women are not included
- Non-viable neonates are not included
- Patients with cognitive impairments are not included
- Patients younger than 18 years old are not included
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Through study completion; an average of 1 year
Participants who have undergone allogeneic hematopoietic stem cell transplantation are observed for safety and adverse events related to belumosudil pharmacokinetics.
Periodic visits for safety assessments
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Amin Alousi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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