Actively Recruiting
Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-08
120
Participants Needed
5
Research Sites
205 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Allogeneic transplant is potentially curative for hematological malignancies but its use is limited by the development of GVHD. Ruxolitinib now has FDA approval for treatment of chronic GVHD that has failed 1-2 prior lines of therapy based on a prior large, randomized phase III study. Given this evidence of safety and efficacy in the early refractory setting (after prednisone failure), Ruxolitinib represents an ideal agent to test in the primary therapy setting. Here investigators propose a phase 2 randomized study to compare Ruxolitinib to prednisone as a first-line therapy in the treatment of chronic GVHD.
CONDITIONS
Official Title
Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Karnofsky performance status of 60% or higher
- Diagnosis of chronic GVHD by NIH criteria requiring first systemic therapy
- No new immune suppressive therapy started within 2 weeks before enrollment
- Ability to take oral medications
- Adequate organ and marrow function including neutrophil count ≥ 1,000/mcL, platelets ≥ 30,000/mcL, hemoglobin ≥ 7 g/dL, bilirubin ≤ 3 times institutional upper limit of normal unless due to GVH, AST/ALT ≤ 5 times institutional upper limit of normal unless due to GVH, creatinine clearance ≥ 30 ml/min
- Willingness to use adequate contraception during and after the study
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior systemic immune suppressive therapy for chronic GVHD
- Clinically significant or uncontrolled cardiovascular disease including unstable angina, recent heart attack or stroke within 6 months, or severe heart failure
- Relapsed malignancy after transplant
- Active hepatitis B, hepatitis C, or HIV infection
- Any uncontrolled infection at enrollment
- Allergy to compounds similar to Ruxolitinib
- Psychiatric illness or social situations limiting compliance
- Pregnancy or lactation
- Current or history of active tuberculosis
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Univ of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
4
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
5
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Actively Recruiting
Research Team
S
Sarah Starr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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