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Clinical Study of Eflornithine After Immunotherapy for High-risk Neuroblastoma（CSHEIN） | Clinical Trials | Clareo Health

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Clinical Study of Eflornithine After Immunotherapy for High-risk Neuroblastoma（CSHEIN）

NCT07278674•Shanghai Children's Hospital

View on ClinicalTrials.gov

Summary

Evaluate the impact of maintenance therapy with eflornithine on event-free survival and overall survival in high-risk neuroblastoma (NB) children after immunotherapy, and assess its safety.

Detailed Description

The investigators plan to recruit 20 participants and divide them into Group A and Group B based on their clinical status. The inclusion criteria for Group A are: newly diagnosed high-risk neuroblastoma (NB) patients who have completed the standard treatment plan (including immunotherapy) and whose disease has reached complete response (CR) or very good partial response (VGPR). The inclusion criteria for Group B are: recurrent or refractory NB patients who have completed any treatment for recurrent disease, or who have achieved disease stability after any salvage or intensification therapy for primary refractory disease, with at least a partial response (PR) as assessed by CT or MRI and negative bone marrow aspiration. There are no restrictions regarding gender or geographic region. Participants must be under 18 years of age. Eligible subjects will be enrolled into the study after receiving the first oral dose of eflornithine, with a total treatment course of 2 years. Follow-up will continue for up to 3 years after completion of eflornithine therapy.

Eligibility

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. According to the International Neuroblastoma Risk Group Classification, it has been histologically diagnosed as high-risk NB.
•2. Under the age of 18.
•3. The disease assessment status is PR (via CT or MRI) and the bone marrow smear is negative.
•4. If the residual mass is MIBG negative or MIBG positive and lacks FDG-PET affinity, it is considered evidence that the mass does not represent active disease. Subjects with stable residual tumor mass visible on CT/MRI will be included in the study.
•5. Qualified hematological parameters and organ function; Refer to the CI CTC 4.0 adverse reaction grading standard of grade 2 and below.
•6. Eflornithine needs to be activated within 120 days after the completion of previous treatment.

Exclusion Criteria

•1. According to the International Neuroblastoma Risk Group Classification, it has been histologically diagnosed as non high risk NB.
•2. Prior to enrollment, the disease assessment status was either progressive disease (PD) or relapse (via CT or MRI).
•3. Positive bone marrow smear.
•4. Hematological parameters and organ function are not qualified, according to the CI CTC 4.0 adverse reaction grading standard of grade 3 or above.
•5. The guardian does not agree to participate.

Locations (1)

Ruijin Hospital Hainan Branch, affiliated with Shanghai Jiao Tong University School of Medicine and Children's Hospital of Shanghai, affiliated with Shanghai Jiao Tong University School of Medicine

Hainan, China

Key Dates

Start Date

April 8, 2025

Primary Completion Date

October 31, 2029

Completion Date

October 31, 2029

Last Updated

December 12, 2025

Enrollment

ESTIMATED participants

Conditions

High Risk Neuroblastoma

Interventions

Oral administration of eflornithine for the prevention of high-risk neuroblastoma

DRUG

Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma

NCT01041638

High Risk Neuroblastoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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