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.

Conditions

Recurrent or progression of neuroblastoma or neuroblastoma or neuroblastoma refractory to first-line treatment.

Brief summary

number of cycles aborted due to toxicity, number of cycles in which treatment interruptions due to the occurrence of side effects will be longer than provided for in the treatment protocol, number of episodes of Capillary Leak Syndrome, regardless of severity, number of episodes of cytokine release syndrome, regardless of severity, number of episodes of allergic reactions in CTCAE grade 3 and 4 (version in force at that time), number of hematological toxicities in grade 3 and 4 CTCAE (version in force at that time), Number of neurological toxicity episodes, regardless of severity, the percentage of patients with pupil disorders and / or visual disturbances, proportion of patients with renal or hepatic impairment in CTCAE grade 3 and 4 (version in force at that time), Other side effects in grade 3 and 4 CTCAE (version in force at the time)

Related papers

No related papers found yet.

Interventions

DRUGQarziba 4.5 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
number of cycles aborted due to toxicity, number of cycles in which treatment interruptions due to the occurrence of side effects will be longer than provided for in the treatment protocol, number of episodes of Capillary Leak Syndrome, regardless of severity, number of episodes of cytokine release syndrome, regardless of severity, number of episodes of allergic reactions in CTCAE grade 3 and 4 (version in force at that time), number of hematological toxicities in grade 3 and 4 CTCAE (version in force at that time), Number of neurological toxicity episodes, regardless of severity, the percentage of patients with pupil disorders and / or visual disturbances, proportion of patients with renal or hepatic impairment in CTCAE grade 3 and 4 (version in force at that time), Other side effects in grade 3 and 4 CTCAE (version in force at the time)	—

Measure

Time frame

number of cycles aborted due to toxicity, number of cycles in which treatment interruptions due to the occurrence of side effects will be longer than provided for in the treatment protocol, number of episodes of Capillary Leak Syndrome, regardless of severity, number of episodes of cytokine release syndrome, regardless of severity, number of episodes of allergic reactions in CTCAE grade 3 and 4 (version in force at that time), number of hematological toxicities in grade 3 and 4 CTCAE (version in force at that time), Number of neurological toxicity episodes, regardless of severity, the percentage of patients with pupil disorders and / or visual disturbances, proportion of patients with renal or hepatic impairment in CTCAE grade 3 and 4 (version in force at that time), Other side effects in grade 3 and 4 CTCAE (version in force at the time)

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Countries

Poland

Outcome results

None listed