Condition: Neuroblastoma · Ganglioneuroblastoma · Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
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 improvement of ORR, OS and EFS by overcoming of tumor heterogeneous drug resistance using the synergistic interaction of cytostatic and immunobiological agents in the induction. Protocol include the combination of standard chemotherapy (N5 and N6) with anti-GD2 MAB, which is potentially expected to improve outcomes in patients with high-risk neuroblastoma and ganglioneuroblastoma, 4th stage older 18 months. Currently, treatment with combinations of cytostatics with immunobiological agents is limited due to the risk of complications, which, nevertheless, is controlled with proper monitoring and concomitant therapy. Still no data about use of combination of standard chemotherapy (N5 and N6) with ch14.18/CHO MAB (dinutuximab beta) in induction in primary patients with neuroblastoma. Prospective, interventional trial include patients with neuroblastoma and ganglioneuroblastoma, 4th stage of the high-risk group older 18 months, who will receive combination of standard induction chemotherapy (N5 and N6) with anti-GD2 MAB. Consolidation and post consolidation chemotherapy courses are not the …
This description comes directly from the study's public registry record.
Denis Kachanov, MD,PhD · +7 495 664-77-40 · Denis.Kachanov@fccho-moscow.ru
Elena Smirnova · +7(985)130-61-03 · lena.smirnova@fccho-moscow.ru
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| Research Institute of Pediatric Hematology, Oncology and Immunology | Moscow, Russia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06071897