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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03958916
Other study ID # SCCCG-BL/DLBCL-2017-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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