Status:
RECRUITING
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
Lead Sponsor:
Jagiellonian University
Conditions:
High-Risk Neuroblastoma
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Neuroblastoma (NBL) accounts for 8-10% of all childhood malignancies. It is the most common solid tumor outside the central nervous system in people \<18 years of age. It occurs in 6-11 / 1 million ch...
Eligibility Criteria
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
- Patients with toxicities of ≥3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders.
- Patients with neurological toxicities of ≥2 CTCAE WHO grade.
- Active life-threatening infection until stabilization of the patient's condition.
- Pregnancy and / or lactation.
- Sexually active patients who refuse to use an effective method of contraception.
- 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).
- Lack of informed written consent to treatment.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05272371
Start Date
December 1 2021
End Date
December 31 2026
Last Update
March 9 2022
Active Locations (1)
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1
University Children Hospital
Krakow, Malopolska, Poland, 30-663