DLBCL Treatment in Children and Adolescents

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT04726995
Collaborator
(none)
106
249

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
106 participants
Observational Model:
Other
Time Perspective:
Other
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 :
Jan 1, 2000
Actual Primary Completion Date :
May 31, 2020
Actual Study Completion Date :
Oct 1, 2020

Outcome Measures

Primary Outcome Measures

  1. OS [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

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Principal Investigator: Yizhuo Zhang, Sun Yat-sen University CancerCenter

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yizhuo Zhang, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT04726995
Other Study ID Numbers:
  • DLBCL treatment
First Posted:
Jan 27, 2021
Last Update Posted:
Jan 27, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yizhuo Zhang, professor, Sun Yat-sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2021