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Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy
NCT06660355 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 562 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06660355 reports 4 study locations spanning 2 distinct geographic areas — top geographies include Florida, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06660355?
The interventions under investigation include: Prednisone (DRUG), Ruxolitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06660355?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 562 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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