How whole versus crushed belumosudil tablets behave in people with chronic GVHD
Official title: Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic Graft Versus Host Disease
Run by M.D. Anderson Cancer Center · NCT07127926 · Data updated 2026-11-12
This will test whether taking belumosudil as whole tablets or crushed tablets suspended in water changes how the drug is absorbed in adults with chronic graft-versus-host disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 8 (estimated) |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | February 9, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | August 27, 2026 |
| Trial ID | NCT07127926 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with chronic GVHD after allogeneic HSCT who are willing to attend visits, are not pregnant, are not taking CYP3A4 inducers, and have not received investigational GVHD therapy within 28 days are ideal candidates.
✕Probably not a fit
People with active acute GVHD, those taking CYP3A4 inducers, pregnant individuals, children under 18, or those unable to consent are not likely to benefit from enrollment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational pharmacokinetic comparison measures blood levels of belumosudil after administration as whole tablets versus crushed tablets suspended in water in adults with chronic GVHD following allogeneic HSCT. Participants receive the drug in one of the two forms and have timed blood sampling to define concentration over time and key PK parameters. Key exclusions include active acute GVHD, recent investigational GVHD therapy, and use of CYP3A4 inducers; pregnant people and those under 18 are not eligible. The work is conducted at a single center with experienced transplant investigators and laboratory PK analysis.
Why it matters
Potential benefit: If crushed and whole tablets produce similar drug levels, this could make dosing easier for patients who have trouble swallowing without changing effectiveness.
How similar studies have gone: Belumosudil is an approved therapy for cGVHD, but head-to-head pharmacokinetic comparisons of whole versus crushed tablets are limited, so this addresses a practical but relatively novel question.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Amin Alousi, MD — M.D. Anderson Cancer Center
- Study coordinator: Amin Alousi, MD
- Email: aalousi@mdanderson.org
- Phone: (713) 745-8613
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.