2024-513141-37-00CompletedPhase 3
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.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 25 Mar 2024
- Start date
- 6 May 2024
- Lead sponsor
- Uniwersytet Jagiellonski Collegium Medicum
- Diseases
- Childhood cancers, Neuroblastoma
- EU CT number
- 2024-513141-37-00
- EudraCT number
- 2021-003832-96
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 28
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Radiotherapy within 3 weeks prior to the start of the study.
Other illness
- 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.
Other
- Patients with neurological toxicities of ≥2 CTCAE WHO grade.
- Pregnancy and / or lactation
Who the study is looking for
- 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.
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uniwersytecki Szpital Dzieciecy W Krakowie | Cracow | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.