OncoMatch/Clinical Trials/NCT06071897
Induction Chemoimmunotherapy for Patients With High-risk Neuroblastoma
Is NCT06071897 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies monoclonal antibodies GD2 for neuroblastoma.
Treatment: monoclonal antibodies GD2 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Biomarker criteria
Excluded: MYCN amplification
Disease stage
Required: Stage IV
Excluded: Stage I, II, III, 4S
Metastatic disease required
Lab requirements
Blood counts
prothrombin index (PTI) 70-120%, activated partial thromboplastin time (APTT) < 36 s
Kidney function
creatinine clearance or glomerular filtration rate (GFR) > 60 ml/min/1.73 m2
Liver function
alanine aminotransferase (ALT)/aspartate aminotransferase (AST) activity < 5 values of the upper limit of the norm (VGN)
Cardiac function
Absence of clinical signs of heart failure, left ventricular ejection fraction (LVEF) ≥ 55%
Adequate liver function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) activity < 5 values of the upper limit of the norm (VGN). Adequate renal function: creatinine clearance or glomerular filtration rate (GFR) > 60 ml/min/1.73 m2. Coagulogram parameters: prothrombin index (PTI) 70-120%, activated partial thromboplastin time (APTT) < 36 s. Absence of clinical signs of heart failure, left ventricular ejection fraction (LVEF) ≥ 55%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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