RecruitingNCT06574698

Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma

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


Sponsor

Guangzhou Women and Children's Medical Center

Enrollment

64 participants

Start Date

May 6, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 1 YearMax Age: 21 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria2

  • 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.

Interventions

DRUGAddition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy

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


Locations(1)

Guangzhou Women And Children's Medical Center

Guanzhou, Guangdong, China

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NCT06574698


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