An observational study in Rituximab, Lymphoma, Non-Hodgkin and Pediatric Cancer, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by Sun Yat-sen University · Observational
The trial SCCCG-BL/DLBCL-2017 is a collaborative prospective, multicenters, non-randomized, observational, cohort clinical study with participating centers of the South China Children's Cancer Group-Non-Hodgkin lymphoma group(SCCCG-NHL). The aim of the study is to evaluate efficacy and safety of stratified treatment based on risk factors of childhood and adolescents Burkitt lymphoma(BL)/diffuse large B-cell lymphoma(DLBCL) patients in china.
Research purposes:
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 500 is above the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Burkitt lymphoma/diffuse large B-cell lymphoma patients，age at diagnosis \< 18 years.
Exclusion Criteria:
Event-free survival (EFS)
EFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease or relapse, treatment related death, death of any other cause or diagnosis of secondary malignancies.
Time frame: through study completion, maximal eight years
Immune reconstitution rate (only in intermediate/high risk patients
Immune reconstitution rate is defined as percentage of patients achieving age adjusted serum immunoglobulin levels 12 months after start of treatment.
Time frame: 12 months after start of treatment
Overall survival (OS)
OS is defined as time from start of treatment/randomization up to death of any
Time frame: through study completion, maximal eight years
Relapse-free survival (RFS)
RFS is defined as time from start of treatment/randomization up to event or to date of last contact for patients without event. The following occurrences are defined as an event: non-response, progressive disease, or relapse.
Time frame: through study completion, maximal eight years
Response rate (RR)
Complete response, partial remission, objective effect, stable disease or progressive disease
Time frame: on an average 3 weeks after finish of treatment
Adverse event rate
Rate of patients with acute toxicity defined as grade III/IV/V AE
Time frame: from the first day of protocol defined treatment until two years after start of protocol defined treatment
Rate of patients achieving normal immunoglobulin level 12 months after start of treatment
Rate of patients achieving normal immunoglobulin level 12 months after start of treatment
Time frame: 12 months after start of treatment
Time interval to normal immunoglobulin level
Time interval to normal immunoglobulin level
Time frame: through study completion, maximal eight years
Plan to share: No
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