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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: Recruiting Phase 2 study of Chronic Graft-versus-host Disease (cGVHD), sponsored by H. Lee Moffitt Cancer Center and Research Institute.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment Success is defined as C7D1 NIH CR/PR without death or new line of immune suppressive therapy and will be estimated for both arms.
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 |
What NCT06660355 shows while recruiting
NCT06660355 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Chronic Graft-versus-host Disease (cGVHD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06660355's enrollment target sits among peer trials
120 569th of 2000 higher than 1,384 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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