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NCT06388564 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
A Phase 2 study of Chronic Graft Versus Host Disease, sponsored by Incyte Corporation.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT06388564: Recruiting Phase 2 study of Chronic Graft Versus Host Disease, sponsored by Incyte Corporation.
NCT06388564 is a Phase 2 study of Chronic Graft Versus Host Disease that is actively recruiting participants, run by Incyte Corporation. The registered enrollment target is 120 participants, roughly in line with the 112-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06388564, a Phase 2 study of Chronic Graft Versus Host Disease, is actively recruiting participants, sponsored by Incyte Corporation.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Defined as Complete Response (CR) or Partial Response (PR) at 6 months in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in 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 |
What NCT06388564 shows while recruiting
NCT06388564 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, roughly in line with the 112-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target.
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.
NCT06388564 names 20 study sites across 13 states, led by California, New York, Colorado.
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.
What interventions are being tested in trial NCT06388564?
The interventions under investigation include: Ruxolitinib (DRUG), Corticosteroids (DRUG), Axatilimab (DRUG).
Who is sponsoring clinical trial NCT06388564?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Chronic Graft Versus Host Disease
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 NCT06388564's enrollment target sits among peer trials
120 8th of 30 higher than 22 of 30 other Chronic Graft Versus Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Graft Versus Host Disease 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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