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

Launched by FRED HUTCHINSON CANCER CENTER · Aug 10, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called belumosudil for patients with chronic graft versus host disease (cGVHD), a condition that can occur after stem cell transplants. cGVHD happens when the immune cells from the donor attack the recipient's body, leading to problems in different organs. The trial aims to see if belumosudil can help manage this condition better than a placebo (a treatment that looks like the real drug but has no active ingredients) and possibly reduce the need for other immune-suppressing medications.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of cGVHD, with at least one clear symptom of the disease. You should not have started any new immune-suppressing treatments in the two weeks before joining the study. Before enrolling, participants will undergo screening to ensure they meet specific health criteria, such as certain blood test results and the ability to take oral medications. If you join the trial, you will receive either the study drug or a placebo and be monitored closely by the research team throughout the process. It's also important to note that women who can become pregnant will need to use effective contraception during the study and for three months afterward.

Gender

ALL

Eligibility criteria

• 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
• • Glomerular filtration rate (GFR) \>= 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); or
• • 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