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Compares treatment options for Chronic Graft Versus Host Disease
Official title Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease
ClinicalTrials.gov ID: NCT05996627
What this study is testing
What is Belumosudil?
Belumosudil is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic graft versus host disease.
Also referred to as KD 025, KD-025.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least one diagnostic or distinctive cGVHD manifestation(s), with a clinical diagnosis of cGVHD,but patients do not need to meet National Institute...
- 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...
- Age 18 and older
You likely can't join if
- 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
See the full eligibility 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...
- 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 people 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...
- 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...
- 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 people 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...
- No evidence of active malignancy
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; New York, New York, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.