Active — Not RecruitingNot Applicable

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

China20 participantsStarted 2025-04-08

Plain-language 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.

Who can participate

Age range1 Month – 18 Years

SexALL

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Inclusion criteria

✓. According to the International Neuroblastoma Risk Group Classification, it has been histologically diagnosed as high-risk NB.
✓. Under the age of 18.
✓. The disease assessment status is PR (via CT or MRI) and the bone marrow smear is negative.
✓. 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.
✓. Qualified hematological parameters and organ function; Refer to the CI CTC 4.0 adverse reaction grading standard of grade 2 and below.
✓. Eflornithine needs to be activated within 120 days after the completion of previous treatment.

Exclusion criteria

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

What they're measuring

The event free survival rate after the completion of the first DFMO

Timeframe: 5 years

overall survival rate after the completion of the first DFMO

Timeframe: 5 years

Trial details

NCT IDNCT07278674

SponsorShanghai Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-10-31

View on ClinicalTrials.gov More High Risk Neuroblastoma trials