Actively Recruiting

Phase 3
Age: 12Years +
All Genders
NCT06056297

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

Led by X4 Pharmaceuticals · Updated on 2026-04-13

176

Participants Needed

112

Research Sites

177 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorder for at least 6 months before screening, not caused by medications, infections, or cancer
  • Specific types of congenital neutropenia including isolated permanent forms and those with extra-hematologic or metabolic manifestations
  • Chronic idiopathic or primary autoimmune neutropenia
  • Absolute neutrophil count (ANC) below 1000 cells/µL at screening and baseline with no active infection
  • History of at least 2 infections in the past 12 months requiring antibiotics or healthcare visits, related to neutropenia
  • Stable use of G-CSF or other background therapies for at least 4 weeks before screening and willingness to maintain stable doses during the study
Not Eligible

You will not qualify if you...

  • Secondary neutropenia due to hypersplenism, infection, malignancy, autoimmune diseases, nutritional deficiencies, or drug causes
  • Diagnosis of aplastic anemia, WHIM syndrome, cyclic neutropenia, immune dysregulation syndromes, or bone marrow failure diseases
  • Neutropenia associated with Duffy-null phenotype unless specific genetic variants are present
  • Medical or personal conditions that may affect safety or study completion
  • Prior use of more than one dose of mavorixafor or other CXCR4 antagonists within 6 months
  • Use of pegylated-G-CSF unless congenital neutropenia is confirmed
  • Use of other investigational drugs within 30 days or five half-lives before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 112 locations

1

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

Actively Recruiting

2

UC Irvine

Irvine, California, United States, 92697

Actively Recruiting

3

Orso Health

La Jolla, California, United States, 92037

Actively Recruiting

4

University of California, Los Angeles-UCLA

Los Angeles, California, United States, 90095

Actively Recruiting

5

Orso Health

Torrance, California, United States, 90505

Actively Recruiting

6

University of Southern Florida

St. Petersburg, Florida, United States, 33701

Actively Recruiting

7

Children's Healthcare of Atlanta (CHOA)

Atlanta, Georgia, United States, 30322

Actively Recruiting

8

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

9

Boston Children's Cancer Center

Boston, Massachusetts, United States, 02143

Actively Recruiting

10

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

11

Washington University

St Louis, Missouri, United States, 63130

Actively Recruiting

12

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

13

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

14

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

15

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

16

St. Jude Childrens; Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

17

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

18

Cook Children's Medical Center

Fort Worth, Texas, United States, 76104

Actively Recruiting

19

Texas Children's Hospital/ Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

20

Sarah Cannon Research Institute

Woodland, Texas, United States, 77380

Actively Recruiting

21

University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

22

Froedtert And Medical College Of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

23

Hospital El Cruce

Buenos Aires, Argentina, B1888AAE

Actively Recruiting

24

Instituto de Investigaciones Clínicas Córdoba

Córdoba, Argentina, X5000AAW

Actively Recruiting

25

Santorio 9 de Julio

San Miguel de Tucumán, Argentina, T4000IIH

Actively Recruiting

26

Perth Children's Hospital

Nedlands, Australia, 6009

Actively Recruiting

27

Icon Cancer Centre Southport

Southport, Australia, 4215

Actively Recruiting

28

Ballarat Oncology And Haematology Services

Wendouree, Australia, 3355

Actively Recruiting

29

University of Alberta Hospital

Edmonton, Canada, AB T6G 2R3

Actively Recruiting

30

BC Children's Hospital

Vancouver, Canada, V5Z 4H4

Actively Recruiting

31

Clinica IMBANACO S.A.S

Cali, Colombia, 76004

Actively Recruiting

32

Clínica del Country

Chapinero, Colombia, 0813

Actively Recruiting

33

Hospital Pablo Tobón Uribe

Medellín, Colombia, 500034

Actively Recruiting

34

The University Hospital Brno

Brno, Czechia, 62500

Actively Recruiting

35

Motol University Hospital

Prague, Czechia, 15006

Actively Recruiting

36

Institute of Hematology and Pediatric Oncology - Lyon

Lyon, France, 69008

Actively Recruiting

37

Hôpital Saint Louis

Paris, France, 75010

Actively Recruiting

38

Hospital Armand Trousseau Ap-Hp

Paris, France, 75012

Actively Recruiting

39

Hôpital Necker - Enfants Malade

Paris, France, 75015

Actively Recruiting

40

Centre Hospitalier Universitaire de Rennes

Rennes, France, 75033

Actively Recruiting

41

Institut Universitaire de Cancérologie de Toulouse - Oncopôle

Toulouse, France, 31059

Actively Recruiting

42

LTD "Israeli-Georgian Medical Research Clinic Healthycore"

Tbilisi, Georgia, 112

Actively Recruiting

43

LEPL The First University Clinic of Tbilisi State Medical University

Tbilisi, Georgia, 141

Actively Recruiting

44

JSC K. Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, Georgia, 159

Actively Recruiting

45

LTD Multiprofile Clinic Concilium Medulla

Tbilisi, Georgia, 186

Actively Recruiting

46

Klinik und Poliklinik fur Kinder- und Jugendmedizin, Universitatsklinikum Carl Gustav Carus an der TU

Dresden, Germany, 01307

Actively Recruiting

47

Universitaetsklinikum Carl Gustav Carus Tu Dresden

Dresden, Germany, 01307

Actively Recruiting

48

Hellenic Airforce 251 General Hospital

Athens, Greece, 10177

Actively Recruiting

49

University General Hospital of Heraklion

Heraklion, Greece, 71500

Actively Recruiting

50

The Olympion Private General Clinic

Pátrai, Greece, 26443

Actively Recruiting

51

AHEPA General Hospital of Thessaloniki

Thessaloniki, Greece, 54636

Actively Recruiting

52

CMC Deli Klinika

Budapest, Hungary, 1012

Actively Recruiting

53

Semmelweis University

Budapest, Hungary, 1085

Actively Recruiting

54

Teaching Hospital Markusovszky

Szombathely, Hungary, 9700

Actively Recruiting

55

Indira Gandhi Institute Of Medical Sciences

Patna, Bihar, India, 800014

Withdrawn

56

Nirmal Hospital Private Limited

Surat, Gujarat, India, 395002

Withdrawn

57

Pacific Medical College and Hospital

Udaipur, Rajasthan, India, 313001

Withdrawn

58

Yashoda Hospital

Hyderabad, Telangana, India, 500084

Active, Not Recruiting

59

Ruth Rappaport Children's Hospital, Rambam Health Corporation

Haifa, Israel, 3109601

Actively Recruiting

60

Hadassah University Hospital-ein Kerem

Jerusalem, Israel, 9112001

Actively Recruiting

61

Schneider Children's Medical Center of Israel

Petah Tikva, Israel, 4920235

Actively Recruiting

62

The Chaim Sheba Medical Center

Ramat Gan, Israel, 5265601

Actively Recruiting

63

A. O. U. delle Marche

Torrette, Ancona, Italy, 60126

Actively Recruiting

64

ASST Spedali Civili di Brescia

Brescia, Italy, 25121

Actively Recruiting

65

IRCCS Instituto G. Gaslini

Genova, Italy, 16147

Actively Recruiting

66

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori (IRST) Dino Amadori

Meldola, Italy, 47014

Actively Recruiting

67

IRCCS San Gerardo Dei Tintori

Monza, Italy, 20900

Actively Recruiting

68

Bambino Gesu Children's Hospital

Roma, Italy, PC 00165

Actively Recruiting

69

AOU Città della salute e della scienza di Torino

Torino, Italy, 10126

Actively Recruiting

70

Hospital Pakar Kanak-Kanak UKM

Kuala Lumpur, Malaysia, 56000

Actively Recruiting

71

Unidade Local de Saúde da Região de Aveiro

Aveiro, Portugal, 3810-164

Actively Recruiting

72

Unidade Local de Saude Coimbra - Paediatric Hospital

Coimbra, Portugal, 3000-602

Actively Recruiting

73

Unidade Local de Saude Coimbra - Quinta dos Vales

Coimbra, Portugal, 3041-801

Actively Recruiting

74

Unidade Local de Saude Santa Maria

Lisbon, Portugal, 1649-028

Actively Recruiting

75

Spitalul Clinic Colentina Site 1

Bucharest, Romania, 020125

Actively Recruiting

76

Spitalul Clinic Colentina Site 2

Bucharest, Romania, 020125

Actively Recruiting

77

Institutul Clinic Fundeni

Bucharest, Romania, 022328

Actively Recruiting

78

Institutul Clinic Fundeni

Bucharest, Romania, 22328

Actively Recruiting

79

Spitalul Clinic Județean de Urgență

Târgu Mureş, Romania, 540136

Actively Recruiting

80

University Clinical Centre of Serbia

Belgrade, Serbia, 11000

Actively Recruiting

81

ICO Badalona - Institut Català d'Oncologia

Barcelona, Spain, PC 08916

Actively Recruiting

82

Hospital Del Mar

Barcelona, Spain, PC08003

Actively Recruiting

83

Hospital San Pedro De Alcantara

Cáceres, Spain, 10003

Actively Recruiting

84

Hospital Universitario Reina Sofía

Córdoba, Spain, 14004

Withdrawn

85

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Spain, 35010

Actively Recruiting

86

Hospital De La Princesa

Madrid, Spain, 28006

Actively Recruiting

87

Hospital Universitario Infanta Leonor

Madrid, Spain, 28031

Withdrawn

88

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain, 28040

Actively Recruiting

89

Hospital Universitario Marqués de Valdecilla

Santander, Spain, 39008

Actively Recruiting

90

Hospital Universitario Virgen del Rocio

Seville, Spain, 41013

Actively Recruiting

91

Hospital Universitario y Politecnico de la Fe

Valencia, Spain, 46026

Actively Recruiting

92

Inselspital - University Hospital Bern Site 1

Bern, Switzerland, 3010

Actively Recruiting

93

Inselspital - University Hospital Bern Site 2

Bern, Switzerland, 3010

Actively Recruiting

94

Ramathibodi Hospital

Bangkok, Thailand, 10400

Actively Recruiting

95

Siriraj Hospital

Bangkok, Thailand, 10700

Actively Recruiting

96

Namik Kemal University (Tekirdağ Namık Kemal Üniversitesi)

Tekirdağ, Süleymanpaşa, Turkey (Türkiye), 59030

Actively Recruiting

97

Dr. Abdurrahman Yurtaslan Ankara Oncology Training And Research Hospital

Ankara, Turkey (Türkiye), 6000

Actively Recruiting

98

Ankara University School of Medicine

Ankara, Turkey (Türkiye), 6620

Actively Recruiting

99

Uludag University Faculty Of Medicine

Nilufer, Turkey (Türkiye)

Actively Recruiting

100

Ondokuz Mayis University Medical Faculty Hospital

Samsun, Turkey (Türkiye), 55200

Actively Recruiting

101

Lviv Regional Clinical Diagnostic Centre

Lviv, Oblast, Ukraine, 79010

Actively Recruiting

102

Medical Center Dobrobut-Clinic LLC

Kyiv, Ukraine, 03151

Actively Recruiting

103

Medical Center Ok Clinic of International Institute of Clinical Research LLC

Kyiv, Ukraine, 2091

Actively Recruiting

104

Llc Onto-Med

Kyiv, Ukraine, 3022

Actively Recruiting

105

Communal non-commercial enterprise "Ternopil City Children's Communal Hospital"

Ternopil, Ukraine, 46000

Actively Recruiting

106

Medical Center The Clinic of Hospodarskyy LLC

Ternopil, Ukraine, 46002

Actively Recruiting

107

University Hospital of Wales

Cardiff, United Kingdom, CF14 4XW

Actively Recruiting

108

Cardiff And Vale University Health Board

London, United Kingdom, CF14 4XW

Actively Recruiting

109

Royal Free London Nhs Foundation Trust Royal Free Hospital

London, United Kingdom, NW3 2QG

Actively Recruiting

110

King's College Hospital

London, United Kingdom, SE5 9RS

Actively Recruiting

111

Imperial College Healthcare Nhs Trust - Hammersmith Hospital

London, United Kingdom, W12 0HS

Actively Recruiting

112

Great Ormond street Hospital for Children NHS Trust

London, United Kingdom, WC1N 1DZ

Actively Recruiting

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Research Team

P

Patient Affairs and Advocacy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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