Neuroblastoma
Conditions
Interventions
Cohort1- CR patient:None
Cohort 2 -Relapsed/refractory patients with bone/bone marrow diseases only:None
Cohort 3- Relapsed/refractory patients with residual soft tissue disease or progressive disease:None
Sponsors
Children’s hospital of Fudan university
Eligibility
Sex/Gender
All
Age
1 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=12 months; 2. High-risk neuroblastoma was diagnosed according to the International Neuroblastoma Risk Classification (INRG); 3. Patients treated with naxitamab according to the physician's clinical judgment and adequate doctor-patient communication; 4. Provide written informed consent; 5. Life expectancy >=6 months; 6. Oxygen saturation > 94% without oxygen therapy; 7. Echocardiography: heart function was basically normal (left ventricular ejection fraction >= 50%); 8. Peripheral blood routine: white blood cell >=1×10^9/L, neutrophil count >=0.5×10^9/L, platelet count >=25×10^9/L, hemoglobin > 80g/L; If combined with chemotherapy, ANC>=0.75×10^9/L and PLT>=75×10^9/L were required; 9. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 60mL/(min·1.73m^2); 11. There should be no evidence of systemic infection and any identified infection should be controlled.
Exclusion criteria
Exclusion criteria: 1. Significant organ toxicity; 2. Known or suspected allergic or hypersensitive reaction to anti-GD2 antibody or GM-CSF or its components; 3. Patients will be receiving treatment with another investigational agent while receiving naxitamab or have received treatment with another investigational agent within 4 weeks before starting naxitamab treatment; 4. Patients were eligible and able to participate in, or are currently participating in, active interventional clinical trials for the indicated indications, including naxitamab, as permitted by the investigator's assessment; 5. The patient was determined by the attending physician to be unable to adhere to treatment with naxitamab or to have an existing condition that was likely to increase the severity of toxicity associated with naxitamab treatment; 6. Patients were known to have CNS metastases or prior CNS metastases at the time of starting treatment with naxitamab; 7. The patient's NB disease showed active progression; 8. Patients with active NB disease at the primary site or with soft tissue metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2Y- event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactKuiran Dong
Children‘s hospital of fudan university
Outcome results
None listed