RecruitingPhase 2NCT06660355

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


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

120 participants

Start Date

Dec 23, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Prednisone and a drug called Ruxolitinib for people with chronic graft-versus-host disease (cgvhd). The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRuxolitinib

Ruxolitinib is a Janus kinase inhibitor.

DRUGPrednisone

Prednisone is a glucocorticoid.


Locations(5)

Univ of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

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NCT06660355


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