Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma

Официальное название

Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma: A Prospective, Single-Arm Clinical Study

Обзор

To explore the efficacy of adding anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy for newly diagnosed high risk neuroblastoma patients. To investigate wether anding Naxitamab in the induction phase will improve the response rate at the end of induction therapy and further improve the overall survival rate.

Вмешательства

• Препарат Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy
  Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy

Первичные конечные точки

• The number of the patients of VGPR or CR at the end of induction therapy [Срок оценки: 5 years]

Вторичные конечные точки (5)

• Objective Response Rate (ORR) [Срок оценки: 5 years]
• The number of days a patient survives [Срок оценки: 3 years after the last patient was enrolled]
• The number of days the patient survive without relapse or progression [Срок оценки: 3 years after the last patient was enrolled]
• The objective response rate (ORR) after 6 cycles of treatment. [Срок оценки: 5 years]
• The number of patients with adverse events related to treatment [Срок оценки: 5 years]

Критерии участия

Критерии включения

Neuroblastoma patients who meet certain criteria are eligible for enrollment in the following stages of diagnosis:

• Children with newly diagnosed stage 4 neuroblastoma according to the International Neuroblastoma Staging System (INSS) who meet the following criteria are eligible for enrollment: i. Age > 18 months (> 547 days) regardless of biological characteristics; or ii. Age 12-18 months (365-547 days), with one of the following three unfavorable biological characteristics (MYCN amplification, pathological type of poor histopathological prognosis, and/or DNA index = 1); or iii. MYCN amplification (MYCN signal increase > 4 times compared to reference signal) regardless of age or other biological characteristics.
• Children with newly diagnosed stage 3 INSS neuroblastoma who meet the following criteria are eligible for enrollment: i. MYCN amplification (MYCN signal increase > 4 times compared to reference signal) regardless of age or other biological characteristics; or ii. Age > 18 months (> 547 days), with pathological type of poor histopathological prognosis regardless of MYCN status.
• Children with newly diagnosed stage 2A/2B INSS neuroblastoma with MYCN amplification (MYCN signal increase > 4 times compared to reference signal) regardless of age or other biological characteristics. The subject must be aged ≤ 21 years at the time of initial diagnosis, and must be aged > 12 months at the time of enrollment.

Критерии исключения

Infants less than 1 year old, those aged 12-18 months, INSS stage 4, and all INSS stage 3 patients with favorable biological characteristics (i.e., non-amplified MYCN, good pathological histopathological prognosis, and DNA index >1) are not eligible.

Subjects who have received immunosuppressive treatment (excluding local steroids) within the last 4 weeks prior to enrollment. Subjects who are currently receiving any investigational drug.

Any other medical condition that, in the opinion of the investigator, may interfere with the interpretation of results or affect the subject's ability to provide informed consent, the legal guardian's ability to provide informed consent, and the subject's cooperation and participation in the study, including but not limited to malabsorption syndrome, mental illness, or substance abuse. Subjects with significant comorbidities (any serious medical condition unrelated to cancer or its treatment that is not covered by the detailed exclusion criteria and is expected to interfere with the investigation drug(s) action or significantly increase the severity of the trial treatment toxicity)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Guangzhou Women And Children's Medical Center — Guanzhou

Идентификаторы

NCT: NCT06574698 · neuroblastoma 2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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