Belumosudil treatment for chronic graft versus host disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the effectiveness of belumosudil compared to a placebo in patients suffering from chronic graft versus host disease (cGVHD), a significant complication following stem cell transplantation. Participants are randomly assigned to receive either belumosudil or a placebo for 28-day cycles, with a total of 11 cycles followed by a tapering phase. The study aims to assess the drug's ability to mitigate immune responses associated with cGVHD and potentially reduce the need for additional immunosuppressive therapies. Blood samples will be collected for analysis throughout the study, and patients will be monitored for up to 18 months post-treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Fred Hutch/University of Washington Cancer Consortium
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Stephanie Lee, MD, MPH — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Gaby Desatnik
• Email: gdesatni@fredhutch.org
• Phone: 206-667-1356

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Belumosudil vs Best Available Therapy for chronic graft-versus-host disease

  In people aged 12 and up with chronic graft-versus-host disease, the study tests belumosudil to see if it works better than the doctor’s choice of best available therapy after prior treatments have failed.

  Recruiting at 3 sites Phase 3 Sanofi · Amsterdam and 2 other locations · NCT07771439

• Mindfulness program to help with symptoms in chronic graft-versus-host disease

  A mindfulness-based program is being tested to see if it can reduce patient-reported symptoms for adults with chronic graft-versus-host disease after a stem cell transplant.

  Recruiting City of Hope Medical Center · Duarte, California · NCT07733141

• Madecassoside tablets plus standard therapy for sclered scl-cGVHD after allo-HSCT

  This study tests whether adding madecassoside tablets to standard therapy can help people with scleral chronic graft-versus-host disease after stem cell transplant.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07606703

• Post-transplant dental cleaning to prevent chronic graft-versus-host disease

  This will try a dental cleaning about 28 days after an allogeneic stem cell transplant to see if it lowers the chance of chronic graft-versus-host disease in adult transplant recipients.

  Recruiting Fred Hutchinson Cancer Center · Seattle, Washington · NCT07535008

• Adrixetinib (Q702) for adults with active chronic graft-versus-host disease.

  This trial will test whether the oral drug Adrixetinib (Q702) is safe and helps adults with moderate or severe active chronic graft-versus-host disease who have not responded to standard treatments.

  Recruiting at 8 sites Phase 1 Qurient Co., Ltd. · Barcelona and 7 other locations · NCT07138196

• How whole versus crushed belumosudil tablets behave in people with chronic GVHD

  This will test whether taking belumosudil as whole tablets or crushed tablets suspended in water changes how the drug is absorbed in adults with chronic graft-versus-host disease.

  Recruiting Phase 1 M.D. Anderson Cancer Center · Houston, Texas · NCT07127926

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.