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NCT06660355 · ClinicalTrials.gov registry record · Phase 2
Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy
A Phase 2 study of Chronic Graft-versus-host Disease (cGVHD), sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 4
- Study locations
NCT06660355 is a Phase 2 study of Chronic Graft-versus-host Disease (cGVHD) that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 120 participants. The trial reports 4 study locations across 2 states.
The verdict
NCT06660355, a Phase 2 study of Chronic Graft-versus-host Disease (cGVHD), is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 4
- Study locations
Study 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 Studied
Interventions
- DRUG Prednisone
- DRUG Ruxolitinib
Study Locations (4)
Florida
- Univ of Miami - Sylvester Comprehensive Cancer Center - Miami
- Moffitt Cancer Center - Tampa
Virginia
- University of Virginia Comprehensive Cancer Center - Charlottesville
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-12-23 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06660355
The ClinicalTrials.gov registry entry for NCT06660355 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Graft-versus-host Disease (cGVHD) appearing as the primary indexed condition, and to 2 interventions - of which Prednisone is the first listed.
NCT06660355 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Florida, Virginia.
Frequently Asked Questions
What is clinical trial NCT06660355 about?
NCT06660355 is a clinical study titled "Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy". 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 evi...
What is the current status of trial NCT06660355?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-12-23. Estimated completion is 2028-12.
What conditions does trial NCT06660355 study?
This clinical trial studies the following conditions: Chronic Graft-versus-host Disease (cGVHD).
What interventions are being tested in trial NCT06660355?
The interventions under investigation include: Prednisone (DRUG), Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT06660355?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06660355 being conducted?
This trial has 4 study locations across Florida, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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