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Belumosudil Pharmacokinetics in Chronic Graft Versus Host Disease

This study is looking at how your body handles belumosudil, a medication used for chronic graft-versus-host disease (cGVHD). Researchers want to compare how the drug is absorbed when taken as a whole tablet versus a crushed tablet mixed in water. This is an observational study, meaning researchers will watch and collect information without giving you a specific treatment. They will be looking at the safety and any side effects you might experience over about one year. You might be able to join if you are 18 or older, have had an allogeneic stem cell transplant, and have cGVHD. You cannot participate if you are pregnant, have active acute GVHD, or are taking certain medications that affect a liver enzyme called CYP3A4.

Study design
This is an observational study with a planned enrollment of 8 participants. It is not specified if the study is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07127926

Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic GvHD

Recruiting
PHASE1Ages 18+InterventionalSupportive care
M.D. Anderson Cancer Center
~8 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Belumosudil

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs
Measured over Through study completion; an average of 1 year

Conditions

Chronic Graft Versus Host Disease

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Chronic Graft Versus Host Disease

NCT07127926

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Amin Alousi, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Amin Alousi, MD
[email protected]
(713) 745-8613
Email the study team

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Eligibility criteria

Inclusion

Male and female subjects ≥ 18 years of age with allogeneic HSCT

Exclusion

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.

What this trial measures

  • Safety and adverse events (AEsThrough study completion; an average of 1 year

    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.