A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections
Condition(s) studied
Investigational drug(s) / intervention(s)
Mavorixafor: Mavorixafor will be administered per schedule specified in the arm description.
Placebo: Placebo will be administered per schedule specified in the arm description.
Study summary
The purpose of this study is to demonstrate the efficacy and evaluate the safety and tolerability of mavorixafor in participants with congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent and/or serious infections as assessed by demonstrating its clinical benefit and increasing levels of circulating neutrophils.
Eligibility
Primary outcome measure(s)
- Co-primary Endpoint: Annualized Infection Rate Based on Infections Adjudicated by Blinded Infection Adjudication Committee (BIAC) During the Treatment Period — Up to 52 Weeks
- Co-primary Endpoint: Number of Participants Meeting the Definition of a Positive Absolute Neutrophil Count (ANC) Response — Up to 52 weeks
Positive ANC response: Increase of ANC \>500 cells/microliter (µL) from baseline.
Trial sites (114)
| Facility | City | Region | Status |
|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | Recruiting |
| UC Irvine | Irvine | California | Recruiting |
| Orso Health | La Jolla | California | Recruiting |
| University of California, Los Angeles-UCLA | Los Angeles | California | Recruiting |
| Orso Health | Torrance | California | Withdrawn |
| University of Southern Florida | St. Petersburg | Florida | Recruiting |
| Children's Healthcare of Atlanta (CHOA) | Atlanta | Georgia | Recruiting |
| University of Iowa | Iowa City | Iowa | Recruiting |
| Boston Children's Cancer Center | Boston | Massachusetts | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Washington University | St Louis | Missouri | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | Recruiting |
| St. Jude Childrens; Research Hospital | Memphis | Tennessee | Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | Recruiting |
| Cook Children's Medical Center | Fort Worth | Texas | Recruiting |
| Texas Children's Hospital/ Baylor College of Medicine | Houston | Texas | Recruiting |
| Sarah Cannon Research Institute | Woodland | Texas | Recruiting |
| University of Utah | Salt Lake City | Utah | Recruiting |
| Froedtert And Medical College Of Wisconsin | Milwaukee | Wisconsin | Recruiting |
| Hospital El Cruce | Buenos Aires | Argentina | Recruiting |
| Instituto de Investigaciones Clínicas Córdoba | Córdoba | Argentina | Recruiting |
| Santorio 9 de Julio | San Miguel de Tucumán | Argentina | Recruiting |
| Perth Children's Hospital | Nedlands | Australia | Recruiting |
| Icon Cancer Centre Southport | Southport | Australia | Recruiting |
| Ballarat Oncology And Haematology Services | Wendouree | Australia | Recruiting |
| Universitair Ziekenhuis Leuven | Leuven | Belgium | Recruiting |
| University of Alberta Hospital | Edmonton | Canada | Recruiting |
| BC Children's Hospital | Vancouver | Canada | Recruiting |
| Fundacion Cardiovascular de Colombia-Instituto del Corazon Florida Blanca | Floridablanca | Santander Department | Recruiting |
| Clinica IMBANACO S.A.S | Cali | Colombia | Recruiting |
| Clínica del Country | Chapinero | Colombia | Recruiting |
| Hospital Pablo Tobón Uribe | Medellín | Colombia | Recruiting |
| The University Hospital Brno | Brno | Czechia | Recruiting |
| Motol University Hospital | Prague | Czechia | Recruiting |
| Institute of Hematology and Pediatric Oncology - Lyon | Lyon | France | Recruiting |
| Hôpital Saint Louis | Paris | France | Recruiting |
| Hospital Armand Trousseau Ap-Hp | Paris | France | Recruiting |
+ 74 more sites — see the full list on the official registry below.
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 NCT06056297 on ClinicalTrials.gov ↗ ← All trials in Switzerland