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DLBCL Treatment in Children and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04726995
Recruitment Status : Completed
First Posted : January 27, 2021
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Yizhuo Zhang, Sun Yat-sen University

Study Description
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Brief Summary:
We compared the efficacy and safety of modified NHL-BFM-90 regimen and R-CHOP/CHOP regimen in pediatric (aged 0-14 years) and adolescent（aged 15-18 years）DLBCL patients in a single institution during a 20-year period. we compared the efficacy and safety of modified NHL-BFM-90 regimen and R-CHOP/CHOP regimen in pediatric (aged 0-14 years) and adolescent（aged 15-18 years）DLBCL patients in a single institution during a 20-year period. To our best knowledge, no reports have been previously published regarding the comparison.

Condition or disease Intervention/treatment
Diffuse Large B-cell Lymphoma Other: CHOP and BFM regiments

Detailed Description:

Diffuse large B-cell lymphoma (DLBCL) is an aggressive lymphoma that accounts for approximately 10%-20% of pediatric and adolescent non-Hodgkin's lymphomas (NHLs).

The incidence increases with age, with 37% of NHLs patients being adolescents aged. Poor survival has been demonstrated in adolescents and young adults compared to children with DLBCL. However, the Associazione Italiana Ematologia Oncologia Pediatrica (AIEOP) LNH-97 study showed that age was not a poor prognostic factor in children and adolescents with Burkitt lymphoma (BL) and DLBCL. A conclusion as to whether adolescent age is an independent risk factor has not been reached.

At present, the preferred protocols for adolescent DLBCL patients have not been standardized. Adolescents with cancer have been designated as a vulnerable population, positioned between children and the adult population. Treatment strategies differ between adults and pediatric patients. The pediatric strategy for DLBCL was developed in parallel by the Berlin-Frankfurt-Münster (BFM) and French-American-British/Lymphomes Malins B (FAB/LMB) groups. The combination of rituximab plus Cyclophosphamide, Adriamycin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like chemotherapy regimens are the standard therapy for the treatment of adult patients with DLBCL. There is currently a lack of studies that have compared the treatment outcomes in adolescent patients with DLBCL who were administered pediatric or adult regimens. Hence, we retrospectively analyzed the clinical characteristics and prognostic factors in DLBCL patients, especially the efficacy and safety of the pediatric regimen (modified NHL-BFM-90) and adult regimen (R-CHOP/CHOP), between pediatric and adolescent DLBCL patients.

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 106 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 60 Months
Official Title: Efficacy and Safety Comparison Between R-CHOP/CHOP and Modified NHL-BFM-90 Regimens in Children and Adolescents With Diffuse Large B-cell Lymphoma
Actual Study Start Date : January 1, 2000
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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Intervention Details:
  • Other: CHOP and BFM regiments
    used CHOP and BFM regiments

Outcome Measures
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Primary Outcome Measures :
  1. OS [ Time Frame: through study completion, an average of 58 months ]
    Overall survival (OS) was calculated from the date of diagnosis to death due to any cause or to the date of the last follow-up visit.


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
DLBCL patients aged 0-18 year-old
Criteria

Inclusion Criteria:

  1. patients who were pathologically diagnosed with DLBCL
  2. patients under 18 years of age.

Exclusion Criteria:

  1. Was administered prior chemotherapy;
  2. Patients who could not receive chemotherapy due to severe immunodeficiency or other diseases.
  3. Patients with primary central nervous system lymphomas.
Contacts and Locations
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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): NCT04726995


Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yizhuo Zhang Sun Yat-sen University CancerCenter
More Information
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Responsible Party: Yizhuo Zhang, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04726995    
Other Study ID Numbers: DLBCL treatment
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
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
Keywords provided by Yizhuo Zhang, Sun Yat-sen University:
Children, Adolescent, Treatment, Modified NHL-BFM-90, R-CHOP
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin