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

A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With LBL

Study Description
Brief Summary:
With the development of molecular biology and precise medical treatment, new challenges have been raised in the diagnosis and treatment of non-Hodgkin lymphoma (NHL) in children. In recent years, the criteria for clinical staging and efficacy evaluation of NHL in children have been updated. Recent clinical studies of COG in the United States and LMB in France have confirmed that molecular biological markers such as Notch1, PTEN and LOH6q are significantly associated with the prognosis of T-lymphoblastic lymphoma (T-LBL). These molecular biological markers should be included in the new risk stratification system. High-intensity treatment of high-risk patients will improve survival. Recent studies have also suggested that PET/CT is helpful in evaluating residual lesions in patients with lymphoma after chemotherapy. In order to keep pace with the times in the diagnosis, clinical staging, risk stratification, efficacy evaluation and treatment of NHL in children. SCCCG-LBL-2017 was formulated by South China Children's Cancer Group of Non-Hodgkin lymphoma, which mainly updated in clinical staging, efficacy evaluation, risk stratification, treatment,etc..

Condition or disease
Lymphoma, Non-Hodgkin Lymphoblastic Lymphoma, Childhood PTEN Loss NOTCH1 Gene Mutation Pediatric Cancer

Detailed Description:

Research purpose:

  1. To investigate the efficacy and safety of SCCCG-LBL-2017 in Chinese children with LBL.
  2. To explore the feasibility of risk stratification of T-LBL by combining genotyping.
  3. To investigate the correlation between MDD and MRD in lymphoblastic lymphoma and prognosis.
  4. To investigate the role of PET/CT in the assessment of residual lymphoblastic lymphoma.
  5. To explore the effect of reducing HD-MTX dosage and shortening maintenance therapy time on the efficacy and survival of low-risk LBL patients.
  6. To explore the effect of prolonging the duration of maintenance therapy on the efficacy and survival of high-risk LBL patients.
Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Prospective Multicenter Cohort Study on the Efficacy and Safety of Stratified Treatment of Chinese Children With Lymphoblastic Lymphoma Based on Risk Factors
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.


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: through study completion, maximal eight years ]
    Rate of patients with acute toxicity defined as grade III/IV/V AE


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
lymphoblastic lymphoma patients#age at diagnosis < 18 years old
Criteria

Inclusion Criteria:

  1. Age < 18 years old
  2. Pathologically confirmed lymphoblastic lymphoma
  3. Newly diagnosed patients
  4. Informed consent of guardian of children patients -

Exclusion Criteria:

  1. Age > 18 years old
  2. Recurrent lymphoblastic lymphoma
  3. Secondary immunodeficiency.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Zhen zijun 13609712260 ext +86 zhenzj@sysucc.org.cn
Contact: Sun xiaofei 13600099837 ext +86 sunxf@sysucc.org.cn

Locations
Layout table for location information
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China
Contact: Zhen zijun    13609712260 ext +86    zhenzj@sysucc.org.cn   
Contact: Sun xiaofei    13600099837 ext +86    sunxf@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Study Director: Zhen zijun Sun Yat-sen University
Tracking Information
First Submitted Date May 30, 2019
First Posted Date June 3, 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 30, 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 30, 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: through study completion, maximal eight years ]
    Rate of patients with acute toxicity defined as grade III/IV/V AE
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 A Prospective Multicenters Clinical Cohort Study of Stratified Treatment of Chinese Children With LBL
Official Title A Prospective Multicenter Cohort Study on the Efficacy and Safety of Stratified Treatment of Chinese Children With Lymphoblastic Lymphoma Based on Risk Factors
Brief Summary With the development of molecular biology and precise medical treatment, new challenges have been raised in the diagnosis and treatment of non-Hodgkin lymphoma (NHL) in children. In recent years, the criteria for clinical staging and efficacy evaluation of NHL in children have been updated. Recent clinical studies of COG in the United States and LMB in France have confirmed that molecular biological markers such as Notch1, PTEN and LOH6q are significantly associated with the prognosis of T-lymphoblastic lymphoma (T-LBL). These molecular biological markers should be included in the new risk stratification system. High-intensity treatment of high-risk patients will improve survival. Recent studies have also suggested that PET/CT is helpful in evaluating residual lesions in patients with lymphoma after chemotherapy. In order to keep pace with the times in the diagnosis, clinical staging, risk stratification, efficacy evaluation and treatment of NHL in children. SCCCG-LBL-2017 was formulated by South China Children's Cancer Group of Non-Hodgkin lymphoma, which mainly updated in clinical staging, efficacy evaluation, risk stratification, treatment,etc..
Detailed Description

Research purpose:

  1. To investigate the efficacy and safety of SCCCG-LBL-2017 in Chinese children with LBL.
  2. To explore the feasibility of risk stratification of T-LBL by combining genotyping.
  3. To investigate the correlation between MDD and MRD in lymphoblastic lymphoma and prognosis.
  4. To investigate the role of PET/CT in the assessment of residual lymphoblastic lymphoma.
  5. To explore the effect of reducing HD-MTX dosage and shortening maintenance therapy time on the efficacy and survival of low-risk LBL patients.
  6. To explore the effect of prolonging the duration of maintenance therapy on the efficacy and survival of high-risk LBL patients.
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 lymphoblastic lymphoma patients#age at diagnosis < 18 years old
Condition
  • Lymphoma, Non-Hodgkin
  • Lymphoblastic Lymphoma, Childhood
  • PTEN Loss
  • NOTCH1 Gene Mutation
  • Pediatric Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *
  • Bonn BR, Rohde M, Zimmermann M, Krieger D, Oschlies I, Niggli F, Wrobel G, Attarbaschi A, Escherich G, Klapper W, Reiter A, Burkhardt B. Incidence and prognostic relevance of genetic variations in T-cell lymphoblastic lymphoma in childhood and adolescence. Blood. 2013 Apr 18;121(16):3153-60. doi: 10.1182/blood-2012-12-474148. Epub 2013 Feb 8.
  • Callens C, Baleydier F, Lengline E, Ben Abdelali R, Petit A, Villarese P, Cieslak A, Minard-Colin V, Rullier A, Moreau A, Baruchel A, Schmitt C, Asnafi V, Bertrand Y, Macintyre E. Clinical impact of NOTCH1 and/or FBXW7 mutations, FLASH deletion, and TCR status in pediatric T-cell lymphoblastic lymphoma. J Clin Oncol. 2012 Jun 1;30(16):1966-73. doi: 10.1200/JCO.2011.39.7661. Epub 2012 Apr 30.

*   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 30, 2019)
300
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 lymphoblastic lymphoma
  3. Newly diagnosed patients
  4. Informed consent of guardian of children patients -

Exclusion Criteria:

  1. Age > 18 years old
  2. Recurrent lymphoblastic lymphoma
  3. Secondary immunodeficiency.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Zhen zijun 13609712260 ext +86 zhenzj@sysucc.org.cn
Contact: Sun xiaofei 13600099837 ext +86 sunxf@sysucc.org.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03971318
Other Study ID Numbers SCCCG-LBL-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
Study Director: Zhen zijun Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date May 2019

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