A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)
Condition(s) studied
Investigational drug(s) / intervention(s)
Axatilimab: Axatilimab is a high-affinity antibody targeting the colony stimulating factor 1 receptor (CSF-1R). CSF-1R signaling has been demonstrated in nonclinical studies to be the key regulatory pathway involved in the expansion and infiltration of donor-derived macrophages that mediate the disease processes involved in cGVHD.
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.
Eligibility
Primary outcome measure(s)
- Overall Response Rate (ORR) in the First 6 Cycles as Defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-Versus-Host Disease (cGVHD) — First 6 cycles (up to Cycle 7 Day 1; each cycle = 4 weeks)
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.
Trial sites (121)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham - Children's of Alabama | Birmingham | Alabama | Completed |
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| City of Hope | Duarte | California | Active Not Recruiting |
| University of Southern California Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| University of California, Los Angeles (UCLA) - Medical Center | Los Angeles | California | Completed |
| Stanford Cancer Center | Stanford | California | Active Not Recruiting |
| Children's National Medical Center | Washington D.C. | District of Columbia | Active Not Recruiting |
| University of Florida (UF) | Gainesville | Florida | Completed |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | Active Not Recruiting |
| University of Miami | Miami | Florida | Recruiting |
| AdventHealth Orlando | Orlando | Florida | Completed |
| Moffitt | Tampa | Florida | Active Not Recruiting |
| Emory University | Atlanta | Georgia | Recruiting |
| Northside Hospital | Atlanta | Georgia | Active Not Recruiting |
| The University of Chicago Medical Center (UCMC) | Chicago | Illinois | Recruiting |
| Indiana University Health Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | Active Not Recruiting |
| Franciscan Health Indianapolis | Indianapolis | Indiana | Completed |
| Tulane University Medical Center | New Orleans | Louisiana | Completed |
| Johns Hopkins Kimmel Cancer Center | Baltimore | Maryland | Completed |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Active Not Recruiting |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | Active Not Recruiting |
| University of Michigan | Ann Arbor | Michigan | Active Not Recruiting |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | Completed |
| University of Minnesota | Minneapolis | Minnesota | Completed |
| Mayo Clinic - Rochester | Rochester | Minnesota | Active Not Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | Active Not Recruiting |
| Weill Medical College of Cornell University | New York | New York | Active Not Recruiting |
| Stony Brook University Medical Center | Stony Brook | New York | Active Not Recruiting |
| Wake Forest | Winston-Salem | North Carolina | Completed |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | Completed |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Completed |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | Recruiting |
| The Cleveland Clinic Foundation | Lyndhurst | Ohio | Active Not Recruiting |
| University of Oklahoma - Health Sciences Center | Oklahoma City | Oklahoma | Active Not Recruiting |
| Oregon Health & Science University | Portland | Oregon | Recruiting |
| University of Pittsburgh Medical Center - Hillman Cancer Center | Pittsburgh | Pennsylvania | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Active Not Recruiting |
+ 81 more sites — see the full list on the official registry below.
More Syndax Pharmaceuticals trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04710576 on ClinicalTrials.gov ↗ ← All trials in the UK