Chronic Graft Versus Host DiseasePhase 1NCT07127926
Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic GvHD
A Phase 1 study testing Belumosudil in people with Chronic Graft Versus Host Disease, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The primary objective of the study is to evaluate belumosudil pharmacokinetics of whole tablets and crushed tablets suspended in water in patients suffering from chronic graft-versus-host disease (cGVHD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Graft Versus Host Disease
- What is being tested?
- Belumosudil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2026to 31 Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects ≥ 18 years of age with allogeneic HSCT
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Amin Alousi, MD, 713-745-8613, aalousi@mdanderson.org
Amin Alousi, MD
About this study
Official title: Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic Graft Versus Host Disease
The primary objective of the study is to evaluate belumosudil pharmacokinetics of whole tablets and crushed tablets suspended in water in patients suffering from chronic graft-versus-host disease (cGVHD).
Read the detailed description
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).
- Conditions
- Chronic Graft Versus Host Disease
- Being tested
- Belumosudil
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelumosudilDrug
Given by PO
| Study group | Role | What they receive |
|---|---|---|
| Belumosudil | Experimental | On Days 0 to 7, you will:
• Take whole belumosudil tablet by mouth 1 time a day at same time of the day.
On Day 7, you will then have your 1st pharmacokinetic visit at MD Anderson:
• Blood samples (about 1 teaspoon) will be collected before dosing, and 0.5, 1, 2, 4, 8, 12, and 24 hours after belumosudil dosing.
On Days 8 to 14, you will:
• Take crushed belumosudil tablet by mouth 1 time a day at same time of the day.
On Day 14, you will then have your 2nd pharmacokinetic visit to MD Anderson:
• Blood samples (about 1 teaspoon) will be collected before dosing, and 0.5, 1, 2, 4, 8, 12, and 24 hours after belumosudil dosing. Receives: Drug: Belumosudil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs
Intra patient change in pharmacokinetic parameters will be determined. In addition, it will be evaluated whether crushing the tablet would have clinically significant change in AUC or Cmax, Tmax, which might impact efficacy or safety of belumosudil based on prior belumosudil pharmacokinetic studies. Due to small number of patients in this study, we don't plan to evaluate the impact of crushed belumosudil tablets pharmacokinetics with long-term outcomes.
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start9 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amin Alousi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127926
- Sponsor's protocol ID
- 2025-0041
- Other IDs
- NCI-2025-05161
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No