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

M.D. Anderson Cancer Center

Status: Begins enrollment this month

Conditions: Chronic Graft Versus Host Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07127926

2025-0041

NCI-2025-05161 (Other Identifier)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.