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NCT04710576 · ClinicalTrials.gov record · last posted 2026-06-16

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

Name: A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD) — clinical trial record (NCT04710576)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: AGAVE-201

StatusRecruiting

PhasePhase 2

SponsorSyndax Pharmaceuticals

Started2021-03-04

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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.

Protocol amendment history 2 changes detected by DataLookout

2026-06-17

Trial status changed: Active, Not Recruiting → Recruiting

2026-06-17

Enrollment increased: 241 → 296 participants

Trial Details

NCT Number	NCT04710576
Lead Sponsor	Syndax Pharmaceuticals
Conditions	Chronic Graft-versus-host-disease
Enrollment	296 participants
Start Date	2021-03-04
Primary Completion	2023-04-07 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2026-06-16