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Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease

NCT05996627 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-02-17

No results posted yet for this study

Summary

This phase II trial compares the effect of belumosudil to a placebo in treating patients with chronic graft versus host disease. Chronic graft versus host disease remains a major complication of stem cell transplantation and can involve multiple organ systems. Belumosudil is a ROCK2 selective inhibitor that works to reduce the immune system response causing the chronic graft versus host disease. Giving belumosudil may better treat patients with chronic graft versus host disease and prevent the need for starting additional immune suppressive medications.

Conditions

Interventions

DRUG

Belumosudil

Given PO

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Electronic Health Record Review

Ancillary studies

DRUG

Placebo Administration

Given PO

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Stephanie Lee, MD, MPH · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2028-04-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05996627 on ClinicalTrials.gov