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出境医 / 临床实验 / Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With BL/DLBCL

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

Study Description
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.

Condition or disease
Rituximab Lymphoma, Non-Hodgkin Pediatric Cancer

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : May 5, 2022
Estimated Study Completion Date : May 5, 2025
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. Time interval to normal immunoglobulin level [ Time Frame: through study completion, maximal eight years ]
    Time interval to normal immunoglobulin level


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Burkitt lymphoma/diffuse large B-cell lymphoma patients，age at diagnosis < 18 years.
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
Contacts and Locations

Contacts
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Contact: Sun Xiao-Fei 13600099837 ext +86 sunxf@sysucc.org.cn
Contact: Zhen Zi-Jun 13609712260 ext +86 zhenzj@sysucc.org.cn

Locations
Layout table for location information
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Sun Xiaofei, Master    13600099837 ext 086    sunxf@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Sun Xiaofei, Master Sun Yat-sen University
Tracking Information
First Submitted Date May 20, 2019
First Posted Date May 22, 2019
Last Update Posted Date June 3, 2019
Actual Study Start Date May 5, 2017
Estimated Primary Completion Date May 5, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 20, 2019)
  • 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
  • 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.
  • 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
  • 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
  • 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
  • Time interval to normal immunoglobulin level [ Time Frame: through study completion, maximal eight years ]
    Time interval to normal immunoglobulin level
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Burkitt lymphoma/diffuse large B-cell lymphoma patients，age at diagnosis < 18 years.
Condition
  • Rituximab
  • Lymphoma, Non-Hodgkin
  • Pediatric Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *
  • 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.
  • 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.
  • 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.
  • 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 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 20, 2019) 		500
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 5, 2025
Estimated Primary Completion Date May 5, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Sun Xiao-Fei 13600099837 ext +86 sunxf@sysucc.org.cn
Contact: Zhen Zi-Jun 13609712260 ext +86 zhenzj@sysucc.org.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03958916
Other Study ID Numbers SCCCG-BL/DLBCL-2017-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Xiao-Fei Sun, Sun Yat-sen University
Study Sponsor Sun Yat-sen University
Collaborators Not Provided
Investigators
Principal Investigator: Sun Xiaofei, Master Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date May 2019

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