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

Part of paid clinical trials in Duarte, California.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT05996627
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belumosudil — DRUG
    Given PO
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Placebo Administration — DRUG
    Given PO

Study Details

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. Belumosudil is a ROCK2 selective inhibitor that works to reduce the immune system response causing the chronic graft versus host disease. Giving belumosudil may better treat patients with chronic graft versus host disease and prevent the need for starting additional immune suppressive medications.

Key Dates

Start date
Dec 6, 2023
Status verified
Feb 2026
Primary completion
Apr 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
82 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Sunmin Park, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Joseph Pidala, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Corey Cutler, MD, MPH (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Doris Ponce, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Gaby Desatnik
[email protected]
206-667-1356
Stephanie Lee, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAMoffitt Cancer Center· Tampa, FLDana-Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYFred Hutch/University of Washington Cancer Consortium· Seattle, WA

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