Recruiting
Phase 1

Belumosudil

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07127926

Conditions

Chronic Graft Versus Host Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Belumosudil

Study Details

Brief 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).

Conditions

Chronic Graft Versus Host Disease

Study ID

NCT07127926

Start date

Feb 9, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Belumosudil

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.

Interventions

Belumosudil

Given by PO

Primary outcome measure

  • Safety and adverse events (AEs [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Amin Alousi, MD

(713) 745-8613aalousi@mdanderson.org

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Amin Alousi, MD

713-745-8613aalousi@mdanderson.org

Principal Investigator:

Amin Alousi, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-27.