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Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic GvHD
NCT07127926 · M.D. Anderson Cancer Center
In plain English
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Official title
Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic Graft Versus Host Disease
About this study
Primary Objective:
To evaluate belumosudil pharmacokinetics of whole tablets and crushed tablets suspended in water in patients suffering from chronic graft-versus-host disease (cGVHD).
Eligibility criteria
Inclusion Criteria:
* Male and female subjects ≥ 18 years of age with allogeneic HSCT
Exclusion Criteria:
* Receiving an investigational GVHD treatment within 28 days of study entry; (2) active acute GVHD; and (3) taking any medication known to be CYP3A4 inducers.
* Pregnancy is an exclusion criterion for stem cell transplant. Pregnant women are not included in this study. Non-viable neonates will not be included in this study. Patients with cognitive impairments will not be included in this study. Patients aged less than 18 years old will not be included.
Study design
Enrollment target: 8 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-02-09
Estimated completion: 2027-12-31
Last updated: 2026-02-18
Primary outcomes
- • Safety and adverse events (AEs (Through study completion; an average of 1 year)
Sponsor
M.D. Anderson Cancer Center · other
Contacts & investigators
ContactAmin Alousi, MD · contact · aalousi@mdanderson.org · (713) 745-8613
InvestigatorAmin Alousi, MD · principal_investigator, M.D. Anderson Cancer Center
All locations (1)
The University of Texas M. D. Anderson Cancer CenterRecruiting
Houston, Texas, United States