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 - ChIm-NB-P

Jagiellonian University Medical College0 sites20 target enrollmentSeptember 14, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Recurrent or progression of neuroblastoma or neuroblastoma refractory to first-line treatment
Sponsor: Jagiellonian University Medical College
Enrollment: 20
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

September 14, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Jagiellonian University Medical College

•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 specific antibodies may be eligible for this study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 28
•F.1\.2 Adults (18\-64 years) no

•1\. Patients with toxicities of \=3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders.
•2\. Patients with neurological toxicities of \=2 CTCAE WHO grade.
•3\. Active life\-threatening infection until stabilization of the patient's condition.
•4\. Pregnancy and / or lactation.
•5\. Sexually active patients who refuse to use an effective method of contraception.
•6\. Current treatment with experimental drugs or use of such treatment within 2 weeks before signing the informed consent to participate in the study.
•7\. Radiotherapy within 3 weeks prior to the start of the study.
•8\. 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).
•9\. Lack of informed written consent to treatment.