DINUTUXIMAB BETA for Neuroblastoma (recurrent, progressive, or refractory to first-line treatment)

Inclusion criteria

• {"criterion_text":"- Diagnosis of NBL according to international criteria (International Neuroblastoma Risk Group, INRG).\n- Patients 1-18 years of age with HR-NBL with primary refractory disease, disease progression or recurrence.\n- 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).\n- Life expectancy ≥6 months."}

Exclusion criteria

• {"criterion_text":"- Patients with toxicities of ≥3 CTCAE WHO grade, except hearing impairment, hematological disorders, liver and kidney disorders.\n- Patients with neurological toxicities of ≥2 CTCAE WHO grade.\n- Active life-threatening infection until stabilization of the patient's condition.\n- Pregnancy and / or lactation\n- Radiotherapy within 3 weeks prior to the start of the study."}

Primary endpoints

• {"endpoint_text":"- number of cycles aborted due to toxicity\n- number of cycles in which treatment interruptions due to the occurrence of side effects will be longer than provided for in the treatment protocol\n- number of episodes of Capillary Leak Syndrome, regardless of severity\n- number of episodes of cytokine release syndrome, regardless of severity\n- number of episodes of allergic reactions in CTCAE grade 3 and 4 (version in force at that time)\n- number of hematological toxicities in grade 3 and 4 CTCAE (version in force at that time)\n- Number of neurological toxicity episodes, regardless of severity\n- the percentage of patients with pupil disorders and / or visual disturbances\n- proportion of patients with renal or hepatic impairment in CTCAE grade 3 and 4 (version in force at that time)\n- Other side effects in grade 3 and 4 CTCAE (version in force at the time)","definition_or_measurement_approach":"Not specified in source"}

Poland

Earliest CTIS Part Ii Submission Date

08-04-2024

Latest Decision Or Authorization Date

06-05-2024

Processing Time Days

28

Number Of Sites

1

Number Of Participants

28

Primary sponsor

Full Name

Uniwersytet Jagiellonski Collegium Medicum

Organisation Type

Educational Institution

Country Of Registered Address

Poland