ChIm-NB-PL


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


Description of the study: The main object of the study is to  test the safety and efficacy of dinutuximab beta therapy in combination with chemotherapy for the treatment of patients with relapsed or progressive neuroblastoma and for first-line treatment of neuroblastoma refractory to standard therapy.The primary objective of the study is to evaluate the safety profile of 20 patients receiving dinutuximab beta in combination with chemotherapy compared to historical data from two reference groups:
- group 1 for patients treated with chemotherapy without immunotherapy
- group 2 for patients treated with immunotherapy without chemotherapy in patients with relapsed or progressive or primary resistance to treatment.

The reference groups will consist of 2 groups of 10 patients who meet the inclusion criteria for the target group, but are treated only with chemotherapy (reference group 1) or only with immunotherapy (reference group 2) at the Department of Pediatric Oncology and Hematology in Krakow.

 

 
Sponsor:
Jagiellonian University Medical College

EudraCT number:
2021-003832-96

Project Manager/Main Investigator:
prof. dr hab. n. med. Walentyna Balwierz

Duration of the study:
2021 - 2026

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