Immunotherapy With Dinutuximab Beta in Combination With Chemotherapy for the Treatment of
Safety evaluation and initial efficacy evaluation will be conducted in a group of patients as a non-commercial, open-label clinical trial of dinutuximab beta (Qarziba) phase IIa. The investigational medicinal product will be dinutuximab beta (anti-GD2 antibodies against GD2 disialoganglioside on NBL cells) at a dose of
| Condition(s) | High-Risk Neuroblastoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | Safety evaluation and initial efficacy evaluation will be conducted in a group of patients as a non-commercial, open-label clinical trial of dinutuximab beta (Qarziba) phase IIa. The investigational medicinal product will be dinutuximab beta (anti-GD2 antibodies against GD2 disialoganglioside on NBL cells) at a dose of 10 mg / m2 / day by continuous infusion for 5 days in combination with irinotecan / temozolomide, topotecan / temozolomide or N5 / N6 chemotherapy GPOH protocol. The study group will be patients with recurrent / progression of NBL or disease resistant to first-line treatment, for whom there are currently no standards of management, and the treatment methods used so far do not give a chance to achieve a permanent remission of the disease. After diagnosis of relapse / progress |
| Who can participate | Inclusion Criteria: 1. Diagnosis of NBL according to international criteria (International Neuroblastoma Risk Group, INRG). 2. Patients 1-18 years of age with HR-NBL with primary refractory disease, disease progression or recurrence. 3. Adequate function of vital organs (if abnormal, dysfunction below grade 4 according to the CTC AE WHO classification, except for disorders defined in the exclusion criteria). 4. Life expectancy ≥6 months. 5. Obtaining the informed written consent of the patient and/or statutory representative for the treatment. 6. Female patients of childbearing potential must consent to the use of effective contraception; Breastfeeding patients must consent to the termination of breastfeeding. 7. Patients who have previously received immunotherapy with DB or other anti-GD2 |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Lead sponsor | Jagiellonian University |
| Locations | Krakow, Malopolska, Poland |
| Start date | 2021-12-01 |
| NCT ID | NCT05272371 |
| Official listing | https://clinicaltrials.gov/study/NCT05272371 |