Brazilian Reality in the Diagnosis and Treatment of Diffuse Large B Cell Lymphoma - BRA-DLBCL

Brazilian Reality in the Diagnosis and Treatment of Diffuse Large B Cell Lymphoma - BRA-DLBCL: Multicenter Retrospective Study (Real World Evidence - RWE)

National, multicenter, non-randomized, retrospective observational study (Real World Evidence-RWE) to analyze the epidemiological profile of diffuse large B cell lymphoma, clinical management, treatment in molecular subgroups, progression profile and patient survival outcomes enrolled and treated within the last 6 years (2017 to 2022), in national cancer reference centers.

Study Overview

• Status: Completed
• Conditions: Diffuse Large B Cell Lymphoma

Detailed Description

Diffuse large B-cell lymphoma management is a challenge in clinical setting, as the heterogeneity of conditions due to the molecular complexity of DLBCL may limit treatment response. Other major factor is that in Brazil we lack evidence of treatment response profiling regarding this molecular complexity. To know the epidemiological profile of DLBCL, together with the first-line treatment profile that has been adopted in reference centers, as well as the management of relapsing, is essentially important in generating evidence that add up to actions targeting the improvement of patient care, providing them with better treatments. The Brazilian reality of clinical presentation, management profile, employed treatments and response rate is little known. Considering the Brazilian reality of a continental country, where healthcare services in reference centers present heterogeneous realities, analyzing clinical routine data may generate important evidence (RWE) to comprise the understanding on treatments effectiveness. Generated evidence has the potential to help understanding the reality of Brazilian patients, as well as supporting new regional researches.

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• Brazil
  • Belo Horizonte, Brazil
    • Research Site
  • Recife, Brazil
    • Research Site
  • Salvador, Brazil
    • Research Site
  • Sao Paulo, Brazil
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants diagnosed with diffuse large B-cell lymphoma, who meet the eligibility criteria and have been treated and followed in the study participating sites within the last 6 years (from 2017 to 2022) will be included in the study.

Description

Inclusion Criteria:

• Male and female;
• Age above 18 years old;
• Diagnosis of diffuse large B-cell lymphoma (DLBCL) and high-grade non-Hodgkin B-cell lymphoma at all stagings;
• Lymphoma classified for the cell of origin (GCB - Germinal Center B-Cell lymphoma, and non-germinal center);
• Having first life of treatment information available in institutional medical record;
• Having survival data available in institutional medical record.

Exclusion Criteria:

• No medical record of the molecular subgroup classification;
• Diagnosis of diffuse large B-cell lymphoma, confirmed in the year 2016;
• Patients diagnosed with Transformed Lymphomas.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Diagnosed with diffuse large B-cell lymphoma, and classified regarding the cell of origin; Retrospective data collection will be carried out from the medical records of the participants included in the study. Will be held description of the epidemiological profile and pathological staging of diffuse large B-cell lymphoma conditions (DLBCL/LDGCB), imaging profiling, together with first-line treatment used in subgroups of germinal center or activated B-cell, in patients followed in Brazilian reference cancer treatment centers, within the last 6 years (between 2017 and 2022).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease staging	Description of the staging of diffuse large B-cell lymphoma conditions in patients followed in Brazilian reference cancer treatment centers	Time Frame: 6 years (Time of retrospective observational analysis of the study)
Time between diagnosis and start of treatment	Description of the time between diagnosis and start of treatment	Time Frame: 6 years (Time of retrospective observational analysis of the study)
Progression-free Survival	Progression-free Survival will be evaluated as the time from the beginning of treatment, considering each line of treatment, to the objective progression of tumor or death	Time Frame: 6 years (Time of retrospective observational analysis of the study)
Overall Survival	Overall Survival will be evaluated as the time from the diagnosis of the hematological disease at any staging until all-cause death	Time Frame: 6 years (Time of retrospective observational analysis of the study)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Hospital Israelita Albert Einstein
• Investigators: Principal Investigator: Guilherme Fleury Perini, Hospital Israelita Albert Einstein

Publications and helpful links

Helpful Links

• CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Actual): June 6, 2024
• Study Completion (Actual): June 6, 2024

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Lymphoma; RWE; Diffuse Large B Cell
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: D133HR00022; BRA-DLBCL (Other Identifier: Hospital Israelita Albert Einstein)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No