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NCT07124078 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)
A Phase 2 study of Chronic Graft Versus Host Disease, sponsored by Incyte Corporation.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 20
- Study locations
NCT07124078: Recruiting Phase 2 study of Chronic Graft Versus Host Disease, sponsored by Incyte Corporation.
NCT07124078 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 60 participants, below the 114-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07124078, 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
- 60 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
Primary Outcome
Defined as complete response (CR) or partial response (PR) at 6 months (Cycle 7 Day 1, 28-day cycles) in the absence of new systemic therapy for cGVHD. Responses defined by the 2014 NIH consensus criteria.
Conditions Studied
Interventions
- DRUG INCA034176
- DRUG Best available Treatment (BAT)
Study Locations (20)
Other
- Hôpital Universitaire Des Enfants Reine Fabiola - Brussels
- Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc - Woluwe-Saint-Lambert
- Charite Campus Virchow - Berlin
- Klinikum Der Johann Wolfgang Goethe-Universitaet - Frankfurt am Main
- Universitaetsklinikum Freiburg Zentrum Fuer Kinderheilkunde- Und Jugendmedizin Klinik Iv: Paediatris - Freiburg im Breisgau
- Universitaetsklinikum Hamburg-Eppendorf - Hamburg
- Medizinische Hochschule Hannover (Mhh) - Zentrum Fuer Kinderheilkunde Und Jugendmedizin - Klinik Fue - Hanover
- University Hospital Regensburg - Regensburg
- Irccs - Aou Di Bologna - Sant'Orsola Malpighi - Bologna
- Irccs Istituto G. Gaslini, Universita Di Genova - Genova
- Fondazione Irccs San Gerardo Dei Tintori - Monza
California
- City of Hope Medical Center - Duarte
- Lucile Packard Child Hospital End - Stanford
District of Columbia
- Childrens National Medical Center - Washington D.C.
Florida
- Adventhealth Pediatric Cellular Therapy and Blood and Marrow Transplant - Orlando
Georgia
- Childrens Healthcare of Atlanta - Atlanta
New York
- Memorial Sloan Kettering Cancer Center - New York
North Carolina
- Levine Cancer Institute - Charlotte
Pennsylvania
- Childrens Hospital of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-03-31 |
| Est. Completion | 2029-07-31 |
| Phase | Phase 2 |
What NCT07124078 shows while recruiting
NCT07124078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 114-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Chronic Graft Versus Host Disease appearing as the primary indexed condition, and to 2 interventions - of which INCA034176 is the first listed.
NCT07124078 names 20 study sites across 9 states, led by Other, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT07124078 about?
NCT07124078 is a clinical study titled "A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)". This study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
What is the current status of trial NCT07124078?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-03-31. Estimated completion is 2029-07-31.
What conditions does trial NCT07124078 study?
This clinical trial studies the following conditions: Chronic Graft Versus Host Disease.
What interventions are being tested in trial NCT07124078?
The interventions under investigation include: INCA034176 (DRUG), Best available Treatment (BAT) (DRUG).
Who is sponsoring clinical trial NCT07124078?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07124078 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, New York. 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 NCT07124078's enrollment target sits among peer trials
60 11th of 30 higher than 20 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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