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

StatusRecruiting
PhasePhase 2
Started2024-12-23
View on ClinicalTrials.gov ↗

Amendment history

2026-08-03
minor
Study Status, Eligibility v12
Eligibility criteria+151 characters
[...] lure will be excluded. Relapse malignancy post- transplant. Molecular relapse or Mixed chimerism or treated relapse in remission may be allowed on case by case basis but needs discussion with the study Chair/PI Active hepatitis B, hepatitis C and HIV will be excluded. An [...]
2026-07-29
minor
Study Status, Contacts/Locations v11
Study sites5→6
2026-04-07
minor
Study Status, Contacts/Locations v10
Study sites4→5
2026-03-31
minor
Study Status v9
Re-verified, no change to tracked fields
2026-02-26
minor
Study Status, Contacts/Locations v8
Study sites3→4
Show 7 earlier versions
2026-01-20
minor
Study Status v7
Re-verified, no change to tracked fields
2025-11-20
minor
Study Status, Contacts/Locations v6
Study sites2→3
2025-11-13
minor
Study Status, Contacts/Locations v5
Study sites1→2
2025-09-29
minor
Study Status, Contacts/Locations v4
Study sitescontacts updated at 1 of 1 site
2025-06-11
minor
Study Status v3
Re-verified, no change to tracked fields
2025-03-13
minor
Study Status v2
Primary completion date2028-11→2028-12
Completion date2028-11→2028-12
Start date2024-11-21→2024-12-23
2024-12-24
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-11→confirmed 2024-11-21
Study sitesdetails revised at 1 of 1 site
Study titlerevised
Ruxolitinib Vsvs Prednisone Asas First-line Therapy for CGVHDcGVHD Needing Systemic Therapy
2024-10-24
minor
Original filing
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.
Trial Details
NCT Number NCT06660355
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Incyte Corporation
Conditions Chronic Graft-versus-host Disease (cGVHD)
Enrollment 120 participants
Start Date 2024-12-23
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-05