Clinical Study of Eflornithine After Immunotherapy for High-risk Neuroblastoma（CSHEIN）
NCT ID: NCT07278674
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
20 participants
OBSERVATIONAL
2025-04-08
2029-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
1 Month
18 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Shanghai Children's Hospital
OTHER
Responsible Party
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Principal Investigators
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Jingbo Shao, PhD，chief physician
Role: PRINCIPAL_INVESTIGATOR
Shanghai Children's Hospital
Wen Su, PhD，associate chief physician
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Locations
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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
Countries
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References
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Duke ES, Bradford D, Sinha AK, Mishra-Kalyani PS, Lerro CC, Rivera D, Wearne E, Miller CP, Leighton J, Sabit H, Zhao H, Lane A, Scepura B, Pazdur R, Singh H, Kluetz PG, Donoghue M, Drezner N. US Food and Drug Administration Approval Summary: Eflornithine for High-Risk Neuroblastoma After Prior Multiagent, Multimodality Therapy. J Clin Oncol. 2024 Sep 1;42(25):3047-3057. doi: 10.1200/JCO.24.00546. Epub 2024 Jun 25.
Diccianni MB, Kempinska K, Gangoti JA, Yu AL, Sorkin LS. Anti-GD2 induced allodynia in rats can be reduced by pretreatment with DFMO. PLoS One. 2020 Jul 22;15(7):e0236115. doi: 10.1371/journal.pone.0236115. eCollection 2020.
Salemi F, Alam W, Hassani MS, Hashemi SZ, Jafari AA, Mirmoeeni SMS, Arbab M, Mortazavizadeh SMR, Khan H. Neuroblastoma: Essential genetic pathways and current therapeutic options. Eur J Pharmacol. 2022 Jul 5;926:175030. doi: 10.1016/j.ejphar.2022.175030. Epub 2022 May 20.
Jabbari P, Hanaei S, Rezaei N. State of the art in immunotherapy of neuroblastoma. Immunotherapy. 2019 Jun;11(9):831-850. doi: 10.2217/imt-2019-0018. Epub 2019 May 16.
Pieniazek B, Cencelewicz K, Bzdziuch P, Mlynarczyk L, Lejman M, Zawitkowska J, Derwich K. Neuroblastoma-A Review of Combination Immunotherapy. Int J Mol Sci. 2024 Jul 15;25(14):7730. doi: 10.3390/ijms25147730.
Pinto NR, Applebaum MA, Volchenboum SL, Matthay KK, London WB, Ambros PF, Nakagawara A, Berthold F, Schleiermacher G, Park JR, Valteau-Couanet D, Pearson AD, Cohn SL. Advances in Risk Classification and Treatment Strategies for Neuroblastoma. J Clin Oncol. 2015 Sep 20;33(27):3008-17. doi: 10.1200/JCO.2014.59.4648. Epub 2015 Aug 24.
Newman EA, Abdessalam S, Aldrink JH, Austin M, Heaton TE, Bruny J, Ehrlich P, Dasgupta R, Baertschiger RM, Lautz TB, Rhee DS, Langham MR Jr, Malek MM, Meyers RL, Nathan JD, Weil BR, Polites S, Madonna MB; APSA Cancer committee. Update on neuroblastoma. J Pediatr Surg. 2019 Mar;54(3):383-389. doi: 10.1016/j.jpedsurg.2018.09.004. Epub 2018 Sep 19.
Hubbard AK, Spector LG, Fortuna G, Marcotte EL, Poynter JN. Trends in International Incidence of Pediatric Cancers in Children Under 5 Years of Age: 1988-2012. JNCI Cancer Spectr. 2019 Mar;3(1):pkz007. doi: 10.1093/jncics/pkz007. Epub 2019 Apr 9.
Other Identifiers
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ShanghaiChildrens
Identifier Type: -
Identifier Source: org_study_id
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