Immunotherapy with dinutuximab beta in combination with chemotherapy for the treatment of patients with primary neuroblastoma refractory to standard therapy and with relapsed or progressive disease.
- Conditions
- Recurrent or progression of neuroblastoma or neuroblastoma or neuroblastoma refractory to first-line treatment.MedDRA version: 20.0Level: LLTClassification code: 10029261Term: Neuroblastoma NOS Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-513141-37-00
- Lead Sponsor
- niwersytet Jagiellonski Collegium Medicum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
Diagnosis of NBL according to international criteria (International Neuroblastoma Risk Group, INRG)., Patients 1-18 years of age with HR-NBL with primary refractory disease, disease progression or recurrence., Adequate function of vital organs (if abnormal, dysfunction below grade 4 according to the CTC AE WHO classification, except for disorders defined in the exclusion criteria)., Life expectancy =6 months.
Patients with toxicities of =3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders., Patients with neurological toxicities of =2 CTCAE WHO grade., Active life-threatening infection until stabilization of the patient's condition., Pregnancy and / or lactation, Radiotherapy within 3 weeks prior to the start of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method