- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05996627
Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease
Randomized Phase II Study of Belumosudil vs. Placebo for Preemptive Treatment of Chronic Graft Versus Host Disease
Study Overview
Status
Conditions
Detailed Description
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive belumosudil orally (PO) daily (QD) or twice daily (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.
ARM II: 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.
Patients follow up after completion of study medication at 30 days, and at 60 days if 12 cycles are completed.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Chloe Te
- Phone Number: 206-667-4196
- Email: cte@fredhutch.org
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- Not yet recruiting
- Moffitt Cancer Center
-
Principal Investigator:
- Joseph Pidala, MD, PhD
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Not yet recruiting
- Dana Farber Cancer Institute
-
Principal Investigator:
- Corey Cutler, MD, MPH
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Boston, Massachusetts, United States, 02114
- Not yet recruiting
- Mass General Cancer Center
-
Principal Investigator:
- Zachariah Defilipp, MD
-
-
New York
-
New York, New York, United States, 10065
- Not yet recruiting
- Memorial Sloan Kettering Cancer Center
-
Principal Investigator:
- Doris Ponce, MD
-
-
Washington
-
Seattle, Washington, United States, 98109
- Recruiting
- Fred Hutch/University of Washington Cancer Consortium
-
Principal Investigator:
- Stephanie Lee, MD, MPH
-
Contact:
- Chloe Te
- Phone Number: 206-667-4196
- Email: cte@fredhutch.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (Belumosudil)
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.
|
Undergo blood sample collection
Other Names:
Given PO
Other Names:
Ancillary study
|
Placebo Comparator: Arm II (Placebo)
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.
|
Undergo blood sample collection
Other Names:
Given PO
Ancillary study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to start of subsequent systemic immune suppressive treatment for chronic graft versus host disease (cGVHD)
Time Frame: From first dose of study medication to starting a new systemic immunosuppressive agent for cGVHD therapy, up to 12 months
|
Systemic therapies include any systemic agent given for a cGVHD indication, including extracorporeal photopheresis.
Will use Gray's test.
Point estimates of new systemic immunosuppressive use will be obtained using cumulative incidence estimates.
|
From first dose of study medication to starting a new systemic immunosuppressive agent for cGVHD therapy, up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event-free survival
Time Frame: From randomization to death, malignancy relapse or addition of a new systemic immune suppressive therapy, up to 12 months or end of study
|
Point estimates will be obtained using the method of Kaplan and Meier and the log-rank test will be used to assess the difference between treatment groups.
|
From randomization to death, malignancy relapse or addition of a new systemic immune suppressive therapy, up to 12 months or end of study
|
Overall survival
Time Frame: Up to 12 months or end of study
|
Point estimates will be obtained using the method of Kaplan and Meier and the log-rank test will be used to assess the difference between treatment groups.
|
Up to 12 months or end of study
|
Rate of relapse
Time Frame: Up to 12 months or end of study
|
Point estimates will be obtained using the method of Kaplan and Meier and the log-rank test will be used to assess the difference between treatment groups.
|
Up to 12 months or end of study
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephanie Lee, MD, MPH, Fred Hutch/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Bronchitis
- Bronchiolitis Obliterans
- Bronchiolitis
- Organizing Pneumonia
- Graft vs Host Disease
- Bronchiolitis Obliterans Syndrome
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Belumosudil
Other Study ID Numbers
- RG1123523 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
- 20163 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
- NCI-2023-05293 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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