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NCT04710576 · ClinicalTrials.gov registry record · Phase 2
A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)
A Phase 2 study of Chronic Graft Versus Host Disease, sponsored by Syndax Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 241
- Enrollment target
- 20
- Study locations
NCT04710576: Active Phase 2 study of Chronic Graft Versus Host Disease, sponsored by Syndax Pharmaceuticals.
NCT04710576 is a Phase 2 study of Chronic Graft Versus Host Disease that is active but no longer recruiting, run by Syndax Pharmaceuticals. The registered enrollment target is 241 participants, above the 108-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (123% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04710576, a Phase 2 study of Chronic Graft Versus Host Disease, is active but no longer recruiting, sponsored by Syndax Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 241 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic therapy.
Primary Outcome
The ORR was defined as the percentage of participants with objective response (complete response \[CR\] or partial response \[PR\]). CR was defined as resolution of all manifestations in each organ or site, and PR was defined as improvement in at least 1 organ or site without progression in any other organ or site.
Conditions Studied
Interventions
- DRUG Axatilimab
Study Locations (20)
Florida
- University of Florida (UF) - Gainesville
- Mayo Clinic - Jacksonville - Jacksonville
- University of Miami - Miami
- AdventHealth Orlando - Orlando
- Moffitt - Tampa
California
- City of Hope - Duarte
- University of Southern California Norris Comprehensive Cancer Center - Los Angeles
- University of California, Los Angeles (UCLA) - Medical Center - Los Angeles
- Stanford Cancer Center - Stanford
Alabama
- University of Alabama at Birmingham - Children's of Alabama - Birmingham
- University of Alabama at Birmingham - Birmingham
Georgia
- Emory University - Atlanta
- Northside Hospital - Atlanta
Indiana
- Indiana University Health Melvin and Bren Simon Cancer Center - Indianapolis
- Franciscan Health Indianapolis - Indianapolis
District of Columbia
- Children's National Medical Center - Washington D.C.
Illinois
- The University of Chicago Medical Center (UCMC) - Chicago
Louisiana
- Tulane University Medical Center - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2021-03-04 |
| Est. Completion | 2027-09 |
| Phase | Phase 2 |
What the registry record for NCT04710576 still lists
NCT04710576 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 30 other Chronic Graft Versus Host Disease trials with a reported enrollment target (123% higher).
The record links to 1 condition, with Chronic Graft Versus Host Disease appearing as the primary indexed condition, and to 1 intervention - of which Axatilimab is the first listed.
NCT04710576 names 20 study sites across 10 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT04710576 about?
NCT04710576 is a clinical study titled "A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)". This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic therapy.
What is the current status of trial NCT04710576?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 241 participants. The study started on 2021-03-04. Estimated completion is 2027-09.
What conditions does trial NCT04710576 study?
This clinical trial studies the following conditions: Chronic Graft Versus Host Disease.
What interventions are being tested in trial NCT04710576?
The interventions under investigation include: Axatilimab (DRUG).
Who is sponsoring clinical trial NCT04710576?
This trial is sponsored by Syndax Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04710576 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. 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 NCT04710576's enrollment target sits among peer trials
241 5th of 30 higher than 26 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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