Induction Chemoimmunotherapy for Patients With High-risk Neuroblastoma
Status:
Recruiting
Trial end date:
2029-09-01
Target enrollment:
Participant gender:
Summary
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 subjects for analysis.
Patients with high-risk neuroblastoma and ganglioneuroblastoma, stage 4, older 18 months who
receive combination of standard induction chemotherapy (N5 and N6) with anti-GD2 MAB at the
Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and
Immunology Delayed surgery (if needed) will be done after the 4th or 6th course of induction
therapy and stem cells apheresis after the 2nd-5th course of induction therapy.
Phase:
Phase 3
Details
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology