NCT06660355

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Graft-versus-host Disease (cGVHD)

Interventions

Type	Name	Description
DRUG	Ruxolitinib	Ruxolitinib is a Janus kinase inhibitor.
DRUG	Prednisone	Prednisone is a glucocorticoid.

Timeline

• Start date: 2024-12-23
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2024-10-28
• Last updated: 2026-04-08

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study