Clinical trial NCT03958916: Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With BL/DLBCL
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rituximab
Lymphoma, Non-Hodgkin
Pediatric Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Burkitt lymphoma/diffuse large B-cell lymphoma patients，age at diagnosis \< 18 years.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Event-free survival (EFS)
timeFrame: through study completion, maximal eight years
measure: Immune reconstitution rate (only in intermediate/high risk patients
timeFrame: 12 months after start of treatment
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: through study completion, maximal eight years
measure: Relapse-free survival (RFS)
timeFrame: through study completion, maximal eight years
measure: Response rate (RR)
timeFrame: on an average 3 weeks after finish of treatment
measure: Adverse event rate
timeFrame: from the first day of protocol defined treatment until two years after start of protocol defined treatment
measure: Rate of patients achieving normal immunoglobulin level 12 months after start of treatment
timeFrame: 12 months after start of treatment
measure: Time interval to normal immunoglobulin level
timeFrame: through study completion, maximal eight years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Sun Xiaofei, Master
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. Radiology. 2012 Mar;262(3):956-68. doi: 10.1148/radiol.11110936.
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 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.
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-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.