DLBCL Treatment in Children and Adolescents

Diffuse Large B-cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726995
• Other study ID #: DLBCL treatment
• Status: Completed
• Start date: January 1, 2000
• Est. completion date: October 1, 2020

Study information

• Verified date: January 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 1, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Other:
• CHOP and BFM regiments
used CHOP and BFM regiments

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	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.	through study completion, an average of 58 months