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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03958916
• Other study ID #: SCCCG-BL/DLBCL-2017-001
• Status: Recruiting
• Start date: May 5, 2017
• Est. completion date: May 5, 2025

Study information

• Verified date: May 2022
• Source: Sun Yat-sen University
• Contact: Sun Xiao-Fei
• Phone: 13600099837
• Email: sunxf[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 5, 2025
• Est. primary completion date: May 5, 2022
• 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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (4)

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

Outcome

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