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
Start Date
6/6/2024
Completion Date
11/1/2027
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.
Detailed Description
All participants will continue their pre-study background therapy, defined as the participant's current treatment regimen. Options include, but are not limited to, granulocyte-colony stimulating factor (G-CSF), immunoglobulin replacement therapy, prophylactic antibiotics, or "watchful waiting".
Eligibility Criteria
Age Range: 12 years to No maximum
Interventions
Mavorixafor
Placebo
Conditions
Locations
Phoenix Children's Hospital
Phoenix, Arizona 85016
United States
UC Irvine
Irvine, California 92697
United States
Orso Health
La Jolla, California 92037
United States
University of California, Los Angeles-UCLA
Los Angeles, California 90095
United States
Orso Health
Torrance, California 90505
United States
University of Southern Florida
St. Petersburg, Florida 33701
United States
Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia 30322
United States
University of Iowa
Iowa City, Iowa 52242
United States
Boston Children's Cancer Center
Boston, Massachusetts 02143
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Washington University
St Louis, Missouri 63130
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
St. Jude Childrens; Research Hospital
Memphis, Tennessee 38105
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
Cook Children's Medical Center
Fort Worth, Texas 76104
United States
Texas Children's Hospital/ Baylor College of Medicine
Houston, Texas 77030
United States
Sarah Cannon Research Institute
Woodland, Texas 77380
United States
University of Utah
Salt Lake City, Utah 84112
United States
Froedtert And Medical College Of Wisconsin
Milwaukee, Wisconsin 53226
United States
Hospital El Cruce
Buenos Aires, B1888AAE
Argentina
Instituto de Investigaciones Clínicas Córdoba
Córdoba, X5000AAW
Argentina
Santorio 9 de Julio
San Miguel de Tucumán, T4000IIH
Argentina
Perth Children's Hospital
Nedlands, 6009
Australia
Icon Cancer Centre Southport
Southport, 4215
Australia
Ballarat Oncology And Haematology Services
Wendouree, 3355
Australia
Universitair Ziekenhuis Leuven
Leuven, 3000
Belgium
University of Alberta Hospital
Edmonton, AB T6G 2R3
Canada
BC Children's Hospital
Vancouver, V5Z 4H4
Canada
Fundacion Cardiovascular de Colombia-Instituto del Corazon Florida Blanca
Floridablanca, Santander Department 681003
Colombia
Clinica IMBANACO S.A.S
Cali, 76004
Colombia
Clínica del Country
Chapinero, 0813
Colombia
Hospital Pablo Tobón Uribe
Medellín, 500034
Colombia
The University Hospital Brno
Brno, 62500
Czechia
Motol University Hospital
Prague, 15006
Czechia
Institute of Hematology and Pediatric Oncology - Lyon
Lyon, 69008
France
Hôpital Saint Louis
Paris, 75010
France
Hospital Armand Trousseau Ap-Hp
Paris, 75012
France
Hôpital Necker - Enfants Malade
Paris, 75015
France
Centre Hospitalier Universitaire de Rennes
Rennes, 75033
France
Institut Universitaire de Cancérologie de Toulouse - Oncopôle
Toulouse, 31059
France
LTD "Israeli-Georgian Medical Research Clinic Healthycore"
Tbilisi, 112
Georgia
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 141
Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, 159
Georgia
LTD Multiprofile Clinic Concilium Medulla
Tbilisi, 186
Georgia
Klinik und Poliklinik fur Kinder- und Jugendmedizin, Universitatsklinikum Carl Gustav Carus an der TU
Dresden, 01307
Germany
Universitaetsklinikum Carl Gustav Carus Tu Dresden
Dresden, 01307
Germany
Hellenic Airforce 251 General Hospital
Athens, 10177
Greece
University General Hospital of Heraklion
Heraklion, 71500
Greece
The Olympion Private General Clinic
Pátrai, 26443
Greece
AHEPA General Hospital of Thessaloniki
Thessaloniki, 54636
Greece
CMC Deli Klinika
Budapest, 1012
Hungary
Semmelweis University
Budapest, 1085
Hungary
Teaching Hospital Markusovszky
Szombathely, 9700
Hungary
Indira Gandhi Institute Of Medical Sciences
Patna, Bihar 800014
India
Nirmal Hospital Private Limited
Surat, Gujarat 395002
India
Pacific Medical College and Hospital
Udaipur, Rajasthan 313001
India
Yashoda Hospital
Hyderabad, Telangana 500084
India
Ruth Rappaport Children's Hospital, Rambam Health Corporation
Haifa, 3109601
Israel
Hadassah University Hospital-ein Kerem
Jerusalem, 9112001
Israel
Schneider Children's Medical Center of Israel
Petah Tikva, 4920235
Israel
The Chaim Sheba Medical Center
Ramat Gan, 5265601
Israel
A. O. U. delle Marche
Torrette, Ancona 60126
Italy
ASST Spedali Civili di Brescia
Brescia, 25121
Italy
IRCCS Instituto G. Gaslini
Genova, 16147
Italy
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori (IRST) Dino Amadori
Meldola, 47014
Italy
IRCCS San Gerardo Dei Tintori
Monza, 20900
Italy
Bambino Gesu Children's Hospital
Roma, PC 00165
Italy
AOU Città della salute e della scienza di Torino
Torino, 10126
Italy
Hospital Pakar Kanak-Kanak UKM
Kuala Lumpur, 56000
Malaysia
Unidade Local de Saúde da Região de Aveiro
Aveiro, 3810-164
Portugal
Unidade Local de Saude Coimbra - Paediatric Hospital
Coimbra, 3000-602
Portugal
Unidade Local de Saude Coimbra - Quinta dos Vales
Coimbra, 3041-801
Portugal
Unidade Local de Saude Santa Maria
Lisbon, 1649-028
Portugal
Spitalul Clinic Colentina Site 1
Bucharest, 020125
Romania
Spitalul Clinic Colentina Site 2
Bucharest, 020125
Romania
Institutul Clinic Fundeni
Bucharest, 022328
Romania
Institutul Clinic Fundeni
Bucharest, 22328
Romania
Spitalul Clinic Județean de Urgență
Târgu Mureş, 540136
Romania
University Clinical Centre of Serbia
Belgrade, 11000
Serbia
ICO Badalona - Institut Català d'Oncologia
Barcelona, PC 08916
Spain
Hospital Del Mar
Barcelona, PC08003
Spain
Hospital San Pedro De Alcantara
Cáceres, 10003
Spain
Hospital Universitario Reina Sofía
Córdoba, 14004
Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, 35010
Spain
Hospital De La Princesa
Madrid, 28006
Spain
Hospital Universitario Infanta Leonor
Madrid, 28031
Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Spain
Hospital Universitario Virgen del Rocio
Seville, 41013
Spain
Hospital Universitario y Politecnico de la Fe
Valencia, 46026
Spain
Inselspital - University Hospital Bern Site 1
Bern, 3010
Switzerland
Inselspital - University Hospital Bern Site 2
Bern, 3010
Switzerland
Ramathibodi Hospital
Bangkok, 10400
Thailand
Siriraj Hospital
Bangkok, 10700
Thailand
Namik Kemal University (Tekirdağ Namık Kemal Üniversitesi)
Tekirdağ, Süleymanpaşa 59030
Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Oncology Training And Research Hospital
Ankara, 6000
Turkey (Türkiye)
Ankara University School of Medicine
Ankara, 6620
Turkey (Türkiye)
Uludag University Faculty Of Medicine
Nilufer,
Turkey (Türkiye)
Ondokuz Mayis University Medical Faculty Hospital
Samsun, 55200
Turkey (Türkiye)
Lviv Regional Clinical Diagnostic Centre
Lviv, Oblast 79010
Ukraine
Medical Center Dobrobut-Clinic LLC
Kyiv, 03151
Ukraine
Medical Center Ok Clinic of International Institute of Clinical Research LLC
Kyiv, 2091
Ukraine
Llc Onto-Med
Kyiv, 3022
Ukraine
Communal non-commercial enterprise "Ternopil City Children's Communal Hospital"
Ternopil, 46000
Ukraine
Medical Center The Clinic of Hospodarskyy LLC
Ternopil, 46002
Ukraine
University Hospital of Wales
Cardiff, CF14 4XW
United Kingdom
Cardiff And Vale University Health Board
London, CF14 4XW
United Kingdom
Royal Free London Nhs Foundation Trust Royal Free Hospital
London, NW3 2QG
United Kingdom
King's College Hospital
London, SE5 9RS
United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, W12 0HS
United Kingdom
Great Ormond street Hospital for Children NHS Trust
London, WC1N 1DZ
United Kingdom