Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease
Chronic Graft Versus Host Disease
About this trial
This is an interventional treatment trial for Chronic Graft Versus Host Disease
Eligibility Criteria
Inclusion Criteria: At least one diagnostic or distinctive cGVHD manifestation(s), 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 dose based on routine clinical tapering practices. Increases in prednisone 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 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
Sites / Locations
- Moffitt Cancer Center
- Mass General Cancer Center
- Dana Farber Cancer Institute
- Memorial Sloan Kettering Cancer Center
- Fred Hutch/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I (Belumosudil)
Arm II (Placebo)
Patients receive belumosudil PO QD or BID if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle. Cycles repeat every 28 days for a total of 11 cycles, followed by one cycle of tapering prior to discontinuation, in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study.
Patients receive a placebo PO QD or BID if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle. Cycles repeat every 28 days for a total of 11 cycles, followed by one cycle of tapering prior to discontinuation, in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study.