NCT07278674

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High Risk Neuroblastoma

Interventions

Type	Name	Description
DRUG	Oral administration of eflornithine for the prevention of high-risk neuroblastoma	This study is a single arm clinical observational study and does not involve control interventions

Timeline

• Start date: 2025-04-08
• Primary completion: 2029-10-31
• Completion: 2029-10-31
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study