Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With BL/DLBCL

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Research purposes: To investigate the efficacy and safety of SCCCG-BL/DLBCL-2017 in children with BL and DLBCL. To investigate the effect of rituximab combined with chemotherapy on the survival rate of children with high-risk BL/DLBCL. To investigate the effect of rituximab on immune function in children with high-risk BL/DLBCL. To explore the correlation between MRD detection and the efficacy and survival of children with BL/DLBCL. To explore the role of PET/CT in evaluating residual lesions in children after BL/DLBCL treatment.

Official Title
-----------------
Prospective Multicenters Clinical Cohort Study on Efficacy and Safety of Stratified Treatment for Chinese Children With Burkitt Lymphoma/Diffuse Large B-cell Lymphoma

Conditions
-----------------
Rituximab, Lymphoma, Non-Hodgkin, Pediatric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 18 years old Pathologically confirmed Burkitt lymphoma or diffuse large B-cell lymphoma Newly diagnosed patients Informed consent of guardian of children patients Exclusion Criteria: Pathological components with follicular lymphoma Immunodeficiency Second neoplasm

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 months after start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS is defined as time from start of treatment/randomization up to death of any | 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. | through study completion, maximal eight years | 
| Response rate (RR) | Complete response, partial remission, objective effect, stable disease or progressive disease | 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 | 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 | 12 months after start of treatment | 
| Time interval to normal immunoglobulin level | Time interval to normal immunoglobulin level | through study completion, maximal eight years |