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ACTIVE NOT RECRUITING Phase 2

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

NCT04710576 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 241 participants
Start Date 2021-03-04
Est. Completion 2027-09
Phase Phase 2

Sponsor

Syndax Pharmaceuticals

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04710576

The ClinicalTrials.gov registry entry for NCT04710576 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Syndax Pharmaceuticals, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04710576 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04710576?

The interventions under investigation include: Axatilimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04710576?

This trial is sponsored by Syndax Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial