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Trial Title:
Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma
NCT ID:
NCT06574698
Condition:
Neuroblastoma
GD2 Antibody (Naxitamab)
Conditions: Official terms:
Neuroblastoma
Immunomodulating Agents
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy
Description:
Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy
Arm group label:
High risk Neuroblastoma
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.
Criteria for eligibility:
Study pop:
Newly Diagnosed High risk Neuroblastoma
Sampling method:
Non-Probability Sample
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)
Gender:
All
Minimum age:
1 Year
Maximum age:
21 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangzhou Women And Children's Medical Center
Address:
City:
Guanzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenyue Si, Bachelor
Phone:
+86-(020)-38767270
Email:
feky@gwcmc.org
Start date:
May 6, 2024
Completion date:
December 31, 2032
Lead sponsor:
Agency:
Guangzhou Women and Children's Medical Center
Agency class:
Other
Source:
Guangzhou Women and Children's Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06574698
