Lymphoma, Non-Hodgkin Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | May 5, 2025 |
Est. primary completion date | May 5, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 1 Year to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Bakhshi S, Radhakrishnan V, Sharma P, Kumar R, Thulkar S, Vishnubhatla S, Dhawan D, Malhotra A. Pediatric nonlymphoblastic non-Hodgkin lymphoma: baseline, interim, and posttreatment PET/CT versus contrast-enhanced CT for evaluation--a prospective study. R — View Citation
Goldman S, Smith L, Anderson JR, Perkins S, Harrison L, Geyer MB, Gross TG, Weinstein H, Bergeron S, Shiramizu B, Sanger W, Barth M, Zhi J, Cairo MS. Rituximab and FAB/LMB 96 chemotherapy in children with Stage III/IV B-cell non-Hodgkin lymphoma: a Childr — View Citation
Meinhardt A, Burkhardt B, Zimmermann M, Borkhardt A, Kontny U, Klingebiel T, Berthold F, Janka-Schaub G, Klein C, Kabickova E, Klapper W, Attarbaschi A, Schrappe M, Reiter A; Berlin-Frankfurt-Münster group. Phase II window study on rituximab in newly diag — View Citation
Rosolen A, Perkins SL, Pinkerton CR, Guillerman RP, Sandlund JT, Patte C, Reiter A, Cairo MS. Revised International Pediatric Non-Hodgkin Lymphoma Staging System. J Clin Oncol. 2015 Jun 20;33(18):2112-8. doi: 10.1200/JCO.2014.59.7203. Epub 2015 May 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Overall survival (OS) | OS is defined as time from start of treatment/randomization up to death of any | through study completion, maximal eight years | |
Secondary | 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 | |
Secondary | Response rate (RR) | Complete response, partial remission, objective effect, stable disease or progressive disease | on an average 3 weeks after finish of treatment | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Time interval to normal immunoglobulin level | Time interval to normal immunoglobulin level | through study completion, maximal eight years |
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