Tests dinutuximab beta with chemotherapy in children with relapsed high-risk neuroblastoma
Tests dinutuximab beta with chemotherapy in children with relapsed or resistant neuroblastoma.
Plain-language title generated from the registry record
Registry title: Immunotherapy With Dinutuximab Beta in Combination With Chemotherapy for the Treatment of Patients With Primary Neuroblastoma Refractory to Standard Therapy and With Relapsed or Progressive Disease
Key facts
- Where
- Krakow, PolandSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and young people aged 1 to 18 with high-risk neuroblastoma that did not respond to first treatment, came back, or got worse.
- Age
- 1 to 18 years
- Sex
- All sexes can join.
- Disease stage
- High-risk neuroblastoma that did not respond to first-line treatment (primary refractory), came back (relapse) or got worse (progression).
- Earlier treatment
- Up to 2 cycles of standard chemotherapy are allowed after relapse, progression or resistance, before joining. People who had dinutuximab beta or other anti-GD2 antibodies before may join.
Main reasons for not taking part
- Side effects of grade 3 or higher (CTCAE WHO), except hearing, blood, liver and kidney problems
- Nerve-related side effects of grade 2 or higher
- Active life-threatening infection until the condition is stable
- Pregnancy or breastfeeding
- Experimental drugs within 2 weeks, radiotherapy within 3 weeks, or another clinical trial within 6 months before consent
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 18 years old?
Source: NCT05272371, who can take part
Where in Poland
- University Children HospitalKrakow, PolandContact: Walentyna Balwierz, Prof.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Jagiellonian University
- Trial code
- NCT05272371
- Record updated
- 9 March 2022
- Original description
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.Read full original descriptionShow less
Immunotherapy With Dinutuximab Beta in Combination With Chemotherapy for the Treatment of Patients With Primary Neuroblastoma Refractory to Standard Therapy and With Relapsed or Progressive Disease
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 / progression or resistance to treatment, it is permissible to administer 2 cycles of standard chemotherapy prior to enrollment in the study.
The study plans to recruit 20 patients who will receive 5-7 cycles of DB with chemotherapy. The choice of an appropriate chemotherapy regimen will depend on the patient's prior treatment and tolerance.
The safety assessment will be conducted based on the registration of the types and frequency of adverse reactions identified on the basis of the registration of clinical parameters, symptoms and / or diseases reported by the patient or identified during the intervention and / or follow-up visits, abnormal laboratory and / or imaging test results.
The initial assessment of the effectiveness will consist in comparing the percentage of objective responses obtained and the annual EFS and PFS (imaging tests, including scintigraphy, bone marrow examination and tumor markers). The study also included an exploratory evaluation of the usefulness of immunological, genetic and other studies.
Inclusion: Diagnosis of NBL according to international criteria (International Neuroblastoma Risk Group, INRG); Patients 1-18 years of age with HR-NBL with primary refractory disease, disease progression or recurrence; 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); Life expectancy ≥6 months; Obtaining the informed written consent of the patient and/or statutory representative for the treatment; Female patients of childbearing potential must consent to the use of effective contraception; Breastfeeding patients must consent to the termination of breastfeeding; Patients who have previously received immunotherapy with DB or other anti-GD2 specific antibodies may be eligible for this study.
Exclusion: Current treatment with experimental drugs or use of such treatment within 2 weeks before signing the informed consent to participate in the study; Radiotherapy within 3 weeks prior to the start of the study; Participation in another clinical trial within 6 months before signing the informed consent to participate in the trial (not applicable to clinical trials in 1st line of treatment in HR-NBL); Patients with toxicities of ≥3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders; Active life-threatening infection until stabilization of the patient's condition; Patients with neurological toxicities of ≥2 CTCAE WHO grade; Pregnancy and / or lactation; Sexually active patients who refuse to use an effective method of contraception; Lack of informed written consent to treatment.