New drug may help stem cell transplant patients avoid extra immune suppression
NCT ID NCT05996627
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 3 times
Summary
This study tests whether the drug belumosudil can prevent chronic graft-versus-host disease (cGVHD) from worsening in stem cell transplant recipients. About 82 participants will receive either belumosudil or a placebo. The goal is to see if the drug delays the need for additional immune-suppressing treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 82 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * At least one diagnostic or distinctive cGVHD manifestation(s), with a clinical diagnosis of cGVHD,but patients do not need to meet National Institute of Health (NIH) criteria for cGVHD * If eye involvement only, cGVHD must be confirmed on exam by an ophthalmologist or optometrist * No new immune suppressive therapy added within preceding 2 weeks prior to study enrollment for any indication * Continuation of agents previously given as either GVHD prophylaxis or acute/late acute GVHD therapy are permitted. Modification of dose of these agents for targeting of therapeutic drug levels is permitted, as are decreases in existing prednisone or prednisone equivalent dose based on routine clinical tapering practices. Increases in prednisone or prednisone equivalents are not allowed in the 2 weeks prior to enrollment * Age 18 and older * Karnofsky performance score \>= 70 * Able to take oral medications * Signed informed consent * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN) * Total bilirubin =\< 1.5 x ULN, unless due to Gilbert's disease * Glomerular filtration rate (estimated glomerular filtration rate \[eGFR\]) \>= 30 mL/min/1.73 m\^2 * Female subjects of childbearing potential have a negative serum or urine pregnancy test at screening. Females of childbearing potential are defined as sexually mature females without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, females who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression * Sexually active females of childbearing potential enrolled in the study must agree to use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes: * Intrauterine device (IUD) plus one barrier method * Stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method * 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm) * Surgical sterilization (tubal ligation) * A vasectomized partner * For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug * No evidence of active malignancy Exclusion Criteria: * Any systemic immune suppressive treatment for cGVHD (topical or local therapies are allowed) * Plan to start systemic immune suppressive therapy for cGVHD or increase steroid dose within 14 days after planned start of study medication * 0.25 mg/kg/day or higher prednisone or prednisone equivalent dose at time of screening * History of non-compliance that in the investigator's opinion would interfere with study participation * Uncontrolled psychiatric illness * Female subject who is pregnant or breast feeding * Previous therapy with belumosudil * Known allergy/sensitivity to belumosudil or any other ROCK2 inhibitor * Treatment with another investigational agent within 28 days (or 5 half-lives, whichever is greater) of enrollment
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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City of Hope
RECRUITINGDuarte, California, 91010, United States
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Fred Hutch/University of Washington Cancer Consortium
RECRUITINGSeattle, Washington, 98109, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
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?