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: 1. To investigate the efficacy and safety of SCCCG-BL/DLBCL-2017 in children with BL and DLBCL. 2. To investigate the effect of rituximab combined with chemotherapy on the survival rate of children with high-risk BL/DLBCL. 3. To investigate the effect of rituximab on immune function in children with high-risk BL/DLBCL. 4. To explore the correlation between MRD detection and the efficacy and survival of children with BL/DLBCL. 5. To explore the role of PET/CT in evaluating residual lesions in children after BL/DLBCL treatment.
Study Type
OBSERVATIONAL
Enrollment
500
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGEvent-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
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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