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

Recruiting

• Conditions: Lymphoma, Non-Hodgkin; Pediatric Cancer; Rituximab

• Registration Number: NCT03958916
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2017-05-05
• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-22
• Status Verified: 2022-05
• Primary Completion: 2022-05-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-09
• Study Completion: 2025-05-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	through study completion, maximal eight years	OS is defined as time from start of treatment/randomization up to death of any
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.
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
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
Time interval to normal immunoglobulin level	through study completion, maximal eight years	Time interval to normal immunoglobulin level

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China