Induction Chemoimmunotherapy for Patients With High-risk Neuroblastoma
Recruiting
Phase 3
Interventional Study
Neuroblastoma
Ganglioneuroblastoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 Months – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 15 (estimated)
- Sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Other
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About This Trial
The modern strategy of therapy of high-risk neuroblastoma, stage 4, consists of three phases - induction, consolidation and post- consolidation. Still current approaches demonstrates insufficient levels of ORR (overall response rate), OS (overall survival) and EFS (event free survival).
NB-HR-2023 (neuroblastoma high risk) protocol aimed to investigate tolerability and toxicity and potential impr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Signed informed consent
* Verified diagnosis of neuroblastoma or ganglioneuroblastoma (ICD-10 codes C47.3, C47.4, C47.5, C47.6, C47.8, C47.9, C48, C74.1, C74.9, C76.0, C76.1, C76.2, C76.7, C76.8).
* High-risk patients in accordance with the risk stratification of to the GPOH-N…
Contacts