Adding Of Naxitamb In Induction Therapy For High Risk Neuroblastoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-21
SponsorGuangzhou Women and Children's Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Newly Diagnosed High risk Neuroblastoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Addition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy
DrugAddition of anti-GD2 immunotherapy (Naxitamab) at the stage of induction chemotherapy
Treatment groups
64 Participants
are divided into 1 treatment groupGroup A: High risk Neuroblastoma1 intervention
Trial outcomes
Primary outcomes
1
The number of the patients of VGPR or CR at the end of induction therapy
Measured by cross-sectional computed tomography (CT) or magnetic resonance imaging (MRI) imaging and/or by methyl iodobenzylguanidine (MIBG) or positron emission tomography (PET) scans and bone marrow (BM) responses, evaluated according to the 1993 International Neuroblastoma Response Criteria (INRC), and compared with relevant historical control groups.
Time frame
5 yearsSecondary outcomes
1
Objective Response Rate (ORR)
According to the International Neuroblastoma Response Criteria (INRC) of 1993 and 2017, the proportion of complete or partial responses was calculated in newly diagnosed high-risk group patients with neuroblastoma who received standard induction therapy. The disease status was evaluated by CT or MRI and/or MIBG or PET scans and bone marrow aspiration. After two courses of treatment, the proportion of complete or partial responses was calculated in newly diagnosed high-risk group patients with neuroblastoma who received standard induction therapy after two courses of treatment were completed.
Time frame
5 years2
The number of days a patient survives
The overall survival (OS) of patients receiving standard-induced chemotherapy and GD2 antibody combination therapy.
Time frame
3 years after the last patient was enrolled3
The number of days the patient survive without relapse or progression
The event-free survival (EFS) of patients receiving standard-induced chemotherapy and GD2 antibody combination therapy.
Time frame
3 years after the last patient was enrolled4
The objective response rate (ORR) after 6 cycles of treatment.
The objective response rate (ORR) after 6 cycles of treatment.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov