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

May 5, 2022 updated by: Xiao-Fei Sun, Sun Yat-sen University

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Burkitt lymphoma/diffuse large B-cell lymphoma patients，age at diagnosis < 18 years.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival (EFS)
Time Frame: 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.
through study completion, maximal eight years
Immune reconstitution rate (only in intermediate/high risk patients
Time Frame: 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.
12 months after start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event rate
Time Frame: 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
from the first day of protocol defined treatment until two years after start of protocol defined treatment
Overall survival (OS)
Time Frame: through study completion, maximal eight years
OS is defined as time from start of treatment/randomization up to death of any
through study completion, maximal eight years
Relapse-free survival (RFS)
Time Frame: 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.
through study completion, maximal eight years
Response rate (RR)
Time Frame: on an average 3 weeks after finish of treatment
Complete response, partial remission, objective effect, stable disease or progressive disease
on an average 3 weeks after finish of treatment
Rate of patients achieving normal immunoglobulin level 12 months after start of treatment
Time Frame: 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
Time interval to normal immunoglobulin level
Time Frame: through study completion, maximal eight years
Time interval to normal immunoglobulin level
through study completion, maximal eight years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Sun Xiaofei, Master, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2017

Primary Completion (Anticipated)

May 5, 2022

Study Completion (Anticipated)

May 5, 2025

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCCCG-BL/DLBCL-2017-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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