Clinical trial NCT06574698: Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma
Official title: Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma: A Prospective, Single-Arm Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuroblastoma
GD2 Antibody (Naxitamab)
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 64
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly Diagnosed High risk Neuroblastoma

Brief 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 criteria: Inclusion Criteria:

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

1. 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.
2. 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.
3. 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 criteria:

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)

Primary outcomes:
measure: The number of the patients of VGPR or CR at the end of induction therapy
timeFrame: 5 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 5 years
measure: The number of days a patient survives
timeFrame: 3 years after the last patient was enrolled
measure: The number of days the patient survive without relapse or progression
timeFrame: 3 years after the last patient was enrolled
measure: The objective response rate (ORR) after 6 cycles of treatment.
timeFrame: 5 years
measure: The number of patients with adverse events related to treatment
timeFrame: 5 years
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Guangzhou Women And Children's Medical Center
state: Guangdong
Study officials:
References: