NCT05272371RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 9 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 1 Mar 2022
- Start date
- 1 Dec 2021
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Jagiellonian University
- Diseases
- Neuroblastoma
- NCT number
- NCT05272371
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 1 Dec 2021 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Children Hospital Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.