Study of belumosudil for cGVHD in diverse patients withdrawn
NCT ID NCT05567406
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to test the safety and effectiveness of the oral drug belumosudil in Black, Native American, and Pacific Islander patients aged 12 and older with chronic graft-versus-host disease (cGVHD) who had already tried at least two other treatments. The goal was to see if the drug could help control the disease without causing serious side effects. However, the study was withdrawn before enrolling any participants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Expected to start
-
Jun 2025
An estimate. Start dates often move.
- Expected to finish
-
Aug 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants are included in the study if any of the following criteria apply: * Participant is Black or African American, or American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander by self-identification. * Previously received at least 2 and not more than 5 lines of systemic therapy for cGVHD. * Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening. * Have persistent cGVHD manifestations and systemic therapy is indicated. * Karnofsky (if aged ≥ 16 years) / Lansky (if aged \< 16 years) Performance Score of ≥ 60. * At least 12 years of age; weight ≥ 40 kilograms (kg). * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN). * Total bilirubin ≤ 1.5 x ULN. * Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants * Capable of giving signed informed consent. Exclusion Criteria: * Participants are excluded from the study if any of the following criteria apply: * Participant has not been on a stable dose/regimen of systemic cGVHD treatment(s) for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus, MMF, methotrexate, rituximab, and ECP are acceptable. Systemic investigational GVHD treatments are not permitted). * Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening. * Current treatment with ibrutinib or ruxolitinib. Prior treatment with ibrutinib or ruxolitinib is allowed with a washout of at least 28 days prior to enrollment. * History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease, or coronary artery disease). * Corrected QT interval using Fridericia's formula (QTc\[F\]) \> 480 ms. * Forced expiratory volume (in the first second; FEV1) ≤ 39% The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic graft versus host disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stem cell infusions put to the test against a tough transplant complication
- Can adding rituximab improve remission in chronic GVHD?
- Can a new pill tame the immune System's attack after stem cell transplants?
- Can a new pill outperform standard care for a tough transplant complication?
- Can meditation tame the Long-Term side effects of a stem cell transplant?
- Could a liquid form of a Graft-Versus-Host disease drug be as effective as the pill?