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Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy

Phase II Randomized Study of Ruxolitinib vs Prednisone as First-Line Therapy for Chronic Graft vs Host Disease Needing Systemic Therapy

NCT06660355•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years.
•Karnofsky performance status ≥60%.
•Patients with a diagnosis of chronic GVHD per NIH diagnostic criteria5 who are in need for first systemic therapy as per treating physician's discretion, Overlap chronic GVHD will be allowed.
•No new immune suppressive therapy added within preceding 2 weeks prior to study enrolment.
•Able to take oral medications.
•Participants must have adequate organ and marrow function as defined below:
•1. absolute neutrophil count ≥1,000/mcL
•2. platelets ≥30,000/mcL
•3. Hemoglobin ≥ 7 g/dL
•4. Bilirubin ≤ 3 times institutional upper limit of normal (ULN) unless attributable to GVH
+3 more criteria

Exclusion Criteria

•Previously treated with systemic immune suppressive therapy for chronic GVHD (where the indication for start of that systemic immune suppressive therapy was chronic GVHD).
•Patients with clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction, or stroke within 6 months, New York Heart Association class III or IV heart failure will be excluded.
•Relapse malignancy post- transplant.
•Active hepatitis B, hepatitis C and HIV will be excluded.
•Any uncontrolled infection at the time if enrollment will be excluded.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ruxolitinib.
•Participants with psychiatric illness/social situations that would limit compliance with study requirements.
•Pregnant women and lactating women are excluded from this study because of the potential for teratogenic or abortifacient effects and an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Ruxolitinib, breastfeeding should be discontinued if the mother is treated with Ruxolitinib.
•Current or history of active Tuberculosis.

Locations (4)

Univ of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Key Dates

Start Date

December 23, 2024

Primary Completion Date

December 1, 2028

Completion Date

December 1, 2028

Last Updated

February 27, 2026

Enrollment

120

ESTIMATED participants

Conditions

Chronic Graft-versus-host Disease (cGVHD)

Interventions

Ruxolitinib

DRUG

Prednisone

DRUG

Contacts

Sarah Starr

CONTACT

813-745-2690 Sarah.Starr@moffitt.org