DLBCL Treatment in Children and Adolescents

NCT ID: NCT04726995

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2000-01-01
• Study Completion Date: 2020-10-01

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.

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.

Conditions

Diffuse Large B-cell Lymphoma

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

CHOP and BFM regiments

used CHOP and BFM regiments

Intervention Type: OTHER

Eligibility 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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yizhuo Zhang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yizhuo Zhang

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University CancerCenter

Other Identifiers

DLBCL treatment

Identifier Type: -

Identifier Source: org_study_id