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A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
NCT06388564 · View on ClinicalTrials.gov ↗
Study Summary
This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.
Conditions Studied
Interventions
- DRUG Ruxolitinib
- DRUG Corticosteroids
- DRUG Axatilimab
Study Locations (20)
California
- City of Hope Medical Center — Duarte
- University of California-Los Angeles Medl Cntr-Oncology Center Bowyer Clinic — Los Angeles
- Stanford Cancer Center — Stanford
New York
- Memorial Sloan Kettering Cancer Center — New York
- Weill Cornell Medicine — New York
- Mount Sinai Hospital — New York
Colorado
- University of Colorado Cancer Center — Aurora
- Colorado Blood Cancer Institute — Denver
Illinois
- Northwestern University — Chicago
- The University of Chicago Medicine — Chicago
Ohio
- Cleveland Clinic — Cleveland
- The Ohio State University — Columbus
Arizona
- Mayo Clinic Hospital — Phoenix
Connecticut
- Smilow Cancer Center-Yale — New Haven
Florida
- Mayo Clinic Jacksonville — Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-10-11 |
| Est. Completion | 2029-12-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06388564
The ClinicalTrials.gov registry entry for NCT06388564 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 Incyte Corporation, which has 163 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 appearing as the primary indexed condition, and to 3 interventions — of which Ruxolitinib 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: NCT06388564 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, New York, Colorado. 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 NCT06388564 about?
NCT06388564 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease". This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.
What is the current status of trial NCT06388564?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-10-11. Estimated completion is 2029-12-01.
What conditions does trial NCT06388564 study?
This clinical trial studies the following conditions: Chronic Graft-versus-host-disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06388564?
The interventions under investigation include: Ruxolitinib (DRUG), Corticosteroids (DRUG), Axatilimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06388564?
This trial is sponsored by Incyte Corporation, which has 163 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06388564 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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