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.
Key facts
- Where
- Cracow, LengyelországSee the site
- Phase
- 3. fázis
Where in Lengyelország
- Uniwersytecki Szpital Dzieciecy W KrakowieCracow, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Uniwersytet Jagiellonski Collegium Medicum
- Trial code
- EU 2024-513141-37-00
- Record updated
- 2024. május 6.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Radiotherapy within 3 weeks prior to the start of the study; Patients with toxicities of ≥3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders; Active life-threatening infection until stabilization of the patient's condition; Patients with neurological toxicities of ≥2 CTCAE WHO grade; Pregnancy and / or lactation.