CSHEINEflornithine for High-risk Neuroblastoma Post-Immunotherapy
This study observes the effects of Eflornithine on children with high-risk neuroblastoma after they have received immunotherapy treatment.
Data Collection
Collected from today forward - ProspectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: April 8, 2025
Actual date on which the first participant was enrolled.This clinical study focuses on examining the effects of a drug called eflornithine on children under 18 years old who have a type of cancer known as high-risk neuroblastoma. The study is particularly interested in patients who have either responded well to previous treatments or have a stable disease after other therapies. By understanding how eflornithine works in these groups, the researchers hope to improve long-term outcomes and provide better treatment options for children with this challenging condition. Participants in this study will be divided into two groups based on their previous treatment responses. Those who have shown a good response to standard treatments, including immunotherapy, will be in one group, while those with stable or partially responsive disease after other therapies will be in another. All participants will receive eflornithine orally for two years, and their health will be monitored for three years after completing the treatment. This careful observation will help determine how effective and safe eflornithine is in managing neuroblastoma in these young patients.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 1 Months to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
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, ChinaOpen 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 in Google Maps