Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With BL/DLBCL
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 5, 2017
CompletedFirst Submitted
Initial submission to the registry
May 20, 2019
CompletedFirst Posted
Study publicly available on registry
May 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2025
CompletedMay 9, 2022
May 1, 2022
5 years
May 20, 2019
May 5, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Overall survival (OS)
through study completion, maximal eight years
Relapse-free survival (RFS)
through study completion, maximal eight years
Response rate (RR)
on an average 3 weeks after finish of treatment
Adverse event rate
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
12 months after start of treatment
- +1 more secondary outcomes
Eligibility Criteria
Burkitt lymphoma/diffuse large B-cell lymphoma patients，age at diagnosis \< 18 years.
You may qualify if:
- Age \< 18 years old
- Pathologically confirmed Burkitt lymphoma or diffuse large B-cell lymphoma
- Newly diagnosed patients
- Informed consent of guardian of children patients
You may not qualify if:
- Pathological components with follicular lymphoma
- Immunodeficiency Second neoplasm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Related Publications (4)
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.
PMID: 25940716RESULTBakhshi 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. Radiology. 2012 Mar;262(3):956-68. doi: 10.1148/radiol.11110936.
PMID: 22357895RESULTGoldman 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 Children's Oncology Group report. Leukemia. 2013 Apr;27(5):1174-7. doi: 10.1038/leu.2012.255. Epub 2012 Sep 3. No abstract available.
PMID: 22940833RESULTMeinhardt 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-Munster group. Phase II window study on rituximab in newly diagnosed pediatric mature B-cell non-Hodgkin's lymphoma and Burkitt leukemia. J Clin Oncol. 2010 Jul 1;28(19):3115-21. doi: 10.1200/JCO.2009.26.6791. Epub 2010 Jun 1.
PMID: 20516455RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sun Xiaofei, Master
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 20, 2019
First Posted
May 22, 2019
Study Start
May 5, 2017
Primary Completion
May 5, 2022
Study Completion
May 5, 2025
Last Updated
May 9, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share