A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

ClinicalTrials.gov ID: NCT04710576

Public ClinicalTrials.gov record NCT04710576. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 3, 2026, 10:10 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients With Recurrent or Refractory Active Chronic Graft Versus Host Disease Who Have Received at Least 2 Lines of Systemic Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04710576
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Syndax Pharmaceuticals; Industry
Enrollment: 296 participants

Conditions and interventions

Conditions

Chronic Graft-versus-host-disease

Interventions

Axatilimab Drug

Drug

Eligibility (public fields only)

Age range: 2 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 3, 2021
Primary completion: Apr 6, 2023
Completion: Aug 31, 2027
Last update posted: Jun 15, 2026

2021 – 2027

United States locations

U.S. sites: 47
U.S. states: 26
U.S. cities: 40

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham - Children's of Alabama	Birmingham	Alabama	35233	Completed
University of Alabama at Birmingham	Birmingham	Alabama	35294	Recruiting
City of Hope	Duarte	California	91010	Active, not recruiting
University of Southern California Norris Comprehensive Cancer Center	Los Angeles	California	90033	Recruiting
University of California, Los Angeles (UCLA) - Medical Center	Los Angeles	California	90059	Completed
Stanford Cancer Center	Stanford	California	94305	Active, not recruiting
Children's National Medical Center	Washington D.C.	District of Columbia	20010	Active, not recruiting
University of Florida (UF)	Gainesville	Florida	32610	Completed
Mayo Clinic - Jacksonville	Jacksonville	Florida	32224	Active, not recruiting
University of Miami	Miami	Florida	33136	Recruiting
AdventHealth Orlando	Orlando	Florida	32806	Completed
Moffitt	Tampa	Florida	33612	Active, not recruiting
Emory University	Atlanta	Georgia	30322	Recruiting
Northside Hospital	Atlanta	Georgia	30342	Active, not recruiting
The University of Chicago Medical Center (UCMC)	Chicago	Illinois	60637	Recruiting
Indiana University Health Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	46202	Active, not recruiting
Franciscan Health Indianapolis	Indianapolis	Indiana	46237	Completed
Tulane University Medical Center	New Orleans	Louisiana	70112	Completed
Johns Hopkins Kimmel Cancer Center	Baltimore	Maryland	21231-2410	Completed
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	02215	Active, not recruiting
University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	01655	Active, not recruiting
University of Michigan	Ann Arbor	Michigan	48084	Active, not recruiting
Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	48201	Recruiting
Henry Ford Hospital	Detroit	Michigan	48202	Completed
University of Minnesota	Minneapolis	Minnesota	55455	Completed
Mayo Clinic - Rochester	Rochester	Minnesota	55905	Active, not recruiting
Washington University School of Medicine	St Louis	Missouri	63110	Recruiting
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	08903	Active, not recruiting
Weill Medical College of Cornell University	New York	New York	10022	Active, not recruiting
Stony Brook University Medical Center	Stony Brook	New York	11794	Active, not recruiting
Wake Forest	Winston-Salem	North Carolina	27157	Completed
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Completed
University Hospitals Cleveland Medical Center	Cleveland	Ohio	44106	Completed
The Ohio State University Comprehensive Cancer Center	Columbus	Ohio	43210	Recruiting
The Cleveland Clinic Foundation	Lyndhurst	Ohio	44195	Active, not recruiting
University of Oklahoma - Health Sciences Center	Oklahoma City	Oklahoma	73104	Active, not recruiting
Oregon Health & Science University	Portland	Oregon	97239	Recruiting
University of Pittsburgh Medical Center - Hillman Cancer Center	Pittsburgh	Pennsylvania	15232	Recruiting
Vanderbilt University Medical Center	Nashville	Tennessee	37232	Active, not recruiting
MD Anderson Cancer Center	Houston	Texas	77030	Active, not recruiting
Intermountain Healthcare	Salt Lake City	Utah	84111	Recruiting
University of Utah	Salt Lake City	Utah	84112	Active, not recruiting
University of Virginia Medical Center	Charlottesville	Virginia	22908	Completed
Fred Hutchinson Cancer Research Center	Seattle	Washington	98109	Recruiting
University of Wisconsin - Carbone Cancer Center	Madison	Wisconsin	53792	Active, not recruiting
Froedtert Hospital and the Medical College of Wisconsin	Milwaukee	Wisconsin	53226	Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 74 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04710576, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 15, 2026 · Synced Sep 3, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04710576 live on ClinicalTrials.gov.

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