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A study to test an oral medicine, belumosudil, in combination with corticosteroids in participants at least 12 years of age with newly diagnosed chronic graft versus host disease.

Primary Objective: Demonstrate the superiority of belumosudil in combination with prednisone vs placebo in combination with prednisone in Event-Free Survival (EFS) Secondary Objective:Demonstrate the superiority of belumosudil in combination with prednisone vs placebo incombination with prednisone in modified Lee Symptom Scale (mLSS) improvement,overall ,response rate (ORR) and in the rate of corticosteroid withdrawal

Age & Gender

12 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

The study includes EKGs, study blood draws, lung function tests, and health questionnaires. You must be willing to take daily medication and complete a pill diary

Incentives

In-person visits:
25

Phone or online visits:
7

Total length of participation:
5 years

Looking for Specific Volunteers

Able to participate:

Participants who have undergone allogenic HCT with newly diagnosed moderate to severe cGVHD
Participants who require systemic treatment with corticosteroids for cGVHD.
Participants who have not received any prior systemic treatment for cGVHD

Not eligible if:

Histological relapse of the underlying disease after most recent allogeneic HCT.
Post-transplant lymphoproliferative disease within 4 weeks prior to randomization
Female participants who are pregnant or breastfeeding.
Unable to tolerate a prednisone equivalent dose of corticosteroids ≥ 1 mg/kg/day.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Janell Markey
janell_markey@med.unc.edu

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

James Coghill
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Leukemia, Lymphoma)
Transplant

IRB Number

23-2140

ClinicalTrials.gov

NCT06143891

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