Naxitamab Added to Induction for Newly Diagnosed High-Risk Neuroblastoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

September 14, 2022

Primary Completion Date

September 30, 2029

Study Completion Date

September 30, 2036

Conditions
High-risk Neuroblastoma
Interventions
DRUG

Naxitamab

Naxitamab is a humanized (IgG1) anti-GD2 (hu3F8) monoclonal antibody for the treatment of neuroblastoma, osteosarcoma and other GD2-positive cancers. Naxitamab was granted accelerated approval by the FDA in 2020 as treatment (in combination with granulocyte-macrophage colony-stimulating factor - GM-CSF) for pediatric patients at least one year of age and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy

Trial Locations (23)

17033

RECRUITING

Penn State Milton S. Hershey Medical Center and Children's Hospital, Hershey

23284

RECRUITING

Virginia Commonwealth University, Richmond

27157

WITHDRAWN

Wake Forest University Health Sciences, Winston-Salem

28204

RECRUITING

Levine Children's Hospital, Charlotte

29425

RECRUITING

Medical University of South Carolina, Charleston

30912

RECRUITING

Augusta University Health, Augusta

32611

RECRUITING

University of Florida, Gainesville

32806

RECRUITING

Arnold Palmer Hospital for Children, Orlando

33155

RECRUITING

Nicklaus Children's Miami, Miami

35201

RECRUITING

University of Alabama, Children's Alabama, Birmingham

40502

RECRUITING

Kentucky Children's Hospital, Lexington

55404

RECRUITING

Children's Hospital and Clinics of Minnesota, Minneapolis

63104

RECRUITING

Cardinal Glennon Children's Hospital, St Louis

72202

RECRUITING

Arkansas Children's Hospital, Little Rock

78723

RECRUITING

Dell Children's Blood and Cancer Center, Austin

92123

RECRUITING

Rady Children's Hospital, San Diego

94609

RECRUITING

UCSF Benioff Children's Hospital Oakland-, Oakland

96813

RECRUITING

Kapiolani Medical Center for Women and Children, Honolulu

97227

RECRUITING

Randall Children's Hospital, Portland

06106

RECRUITING

Connecticut Children's Hospital, Hartford

Unknown

RECRUITING

UHC Sainte-Justine, Montreal

RECRUITING

CHUQ, Québec

RECRUITING

CIUSSS de l'Estrie-CHUS, Sherbrooke

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Y-mAbs Therapeutics

INDUSTRY

lead

Giselle Sholler

OTHER