Lymphoma, Non-Hodgkin, Pediatric Cancer, Rituximab
Conditions
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: 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.
Interventions
None listed
Sponsors
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Inclusion criteria
1. Age \< 18 years old 2. Pathologically confirmed Burkitt lymphoma or diffuse large B-cell lymphoma 3. Newly diagnosed patients 4. Informed consent of guardian of children patients
Exclusion criteria
1. Pathological components with follicular lymphoma 2. Immunodeficiency Second neoplasm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival (EFS) | through study completion, maximal eight years | 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. |
| Immune reconstitution rate (only in intermediate/high risk patients | 12 months after start of treatment | Immune reconstitution rate is defined as percentage of patients achieving age adjusted serum immunoglobulin levels 12 months after start of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate (RR) | on an average 3 weeks after finish of treatment | Complete response, partial remission, objective effect, stable disease or progressive disease |
| Adverse event rate | from the first day of protocol defined treatment until two years after start of protocol defined treatment | Rate of patients with acute toxicity defined as grade III/IV/V AE |
| Overall survival (OS) | through study completion, maximal eight years | OS is defined as time from start of treatment/randomization up to death of any |
| Time interval to normal immunoglobulin level | through study completion, maximal eight years | Time interval to normal immunoglobulin level |
| Rate of patients achieving normal immunoglobulin level 12 months after start of treatment | 12 months after start of treatment | Rate of patients achieving normal immunoglobulin level 12 months after start of treatment |
| Relapse-free survival (RFS) | through study completion, maximal eight years | 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. |
Countries
China
Contacts
Primary ContactSun Xiao-Fei
Backup ContactZhen Zi-Jun
Outcome results
None listed