Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT04501757
Eligibility Criteria:
Inclusion Criteria:
* Patients who are ineligible to participate in study NCT03363373 (IRB# 18-375), will be considered for treatment under this expanded access protocol.
* Diagnosis of NB as defined by a) histopathology (confirmed by the MSK Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels
* Patients must have HR-NB (MYCN-amplified stage 2/3/4/4S of any age and MYCNnonamplified stage 4 in patients greater than 18 months of age).
* Patients must be in first or greater CR or have refractory or relapsed disease
* If previously treated with any anti-GD2 mAb, human anti-hu3F8 antibody (HAHA) titer must be negative.
Exclusion Criteria:
* Active life-threatening infection
* Pregnant women or women who are breastfeeding
* HAHA titer positive
* History of anaphylaxis CTCAE grade 4 to naxitamab
Sex:
ALL
Minimum Age:
18 Months
Study:
NCT04501757
Study Brief:
Protocol Section:
NCT04501757