Chemoimmunotherapy Combined With Autologous NK Cell Therapy for Pediatric Patients With Re
Neuroblastoma (NB) is a malignant neoplasm of the sympathetic nervous system, occurring in 1 in 8,000 live births, accounting for 6-10% of all childhood malignant neoplasms and responsible for 12-15% of mortality -, making it the most common and life-threatening extracranial tumor in childhood. Patients with stage 4 hi
| Condition(s) | Neuroblastoma (NB), Ganglioneuroblastoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Neuroblastoma (NB) is a malignant neoplasm of the sympathetic nervous system, occurring in 1 in 8,000 live births, accounting for 6-10% of all childhood malignant neoplasms and responsible for 12-15% of mortality -, making it the most common and life-threatening extracranial tumor in childhood. Patients with stage 4 high-risk NB is the subgroup with the poorest prognosis. Within this group, two subgroups with an extremely unfavorable disease course are distinguished: patients with a poor response to the induction phase of therapy (refractory disease) and patients with relapsed or progressive disease. Nowadays, 10-15% of patients show a poor end-induction response, whereas achieving a good end-induction response associated with better long-term survival. Improvement of the response to induc |
| Who can participate | Inclusion Criteria: * Signed voluntary informed consent to participate in the clinical trial * Histologically verified diagnosis of neuroblastoma or ganglioneuroblastoma * Patients stratified to the high-risk group according to the criteria of the German Society of Pediatric Oncology and Hematology (GPOH) - NB 2004, aged from 18 months to 18 years, and meeting the following conditions: 1. Arm A: Refractory disease - patients who have completed the induction phase of therapy (6 cycles of N5/N6) with a poor response to therapy (MR, SD), with the exception of PD 2. Arm В: Relapsed/progressive disease - patients who develop any new tumor lesions (after having previously achieved СR), or any new tumor lesion; an increase of \>25% in any previously existing measurable lesion; or newly detected b |
| Ages | 18 Months to 18 Years |
| Sex | All |
| Lead sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
| Locations | Moscow, Russia |
| Start date | 2025-11-19 |
| NCT ID | NCT07375563 |
| Official listing | https://clinicaltrials.gov/study/NCT07375563 |