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RECRUITING
NCT06660355
PHASE2

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-12-23

Completion Date

2028-12

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Ruxolitinib

Ruxolitinib is a Janus kinase inhibitor.

DRUG

Prednisone

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