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

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ClinicalTrials.gov Identifier: NCT03958916
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Xiao-Fei Sun, 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.

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.

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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





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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958916


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

Publications of Results:
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Responsible Party: Xiao-Fei Sun, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03958916     History of Changes
Other Study ID Numbers: SCCCG-BL/DLBCL-2017-001
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases