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

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ClinicalTrials.gov Identifier: NCT05958134
Recruitment Status : Recruiting
First Posted : July 24, 2023
Last Update Posted : May 7, 2024
Sponsor:
Collaborator:
Hospital Israelita Albert Einstein
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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.

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Brazilian Reality in the Diagnosis and Treatment of Diffuse Large B Cell Lymphoma - BRA-DLBCL: Multicenter Retrospective Study (Real World Evidence - RWE)
Actual Study Start Date : July 15, 2023
Estimated Primary Completion Date : May 10, 2024
Estimated Study Completion Date : May 10, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Disease staging [ Time Frame: Time Frame: 6 years (Time of retrospective observational analysis of the study) ]
    Description of the staging of diffuse large B-cell lymphoma conditions in patients followed in Brazilian reference cancer treatment centers

  2. Time between diagnosis and start of treatment [ Time Frame: Time Frame: 6 years (Time of retrospective observational analysis of the study) ]
    Description of the time between diagnosis and start of treatment

  3. Progression-free Survival [ Time Frame: Time Frame: 6 years (Time of retrospective observational analysis of the study) ]
    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

  4. Overall Survival [ Time Frame: Time Frame: 6 years (Time of retrospective observational analysis of the study) ]
    Overall Survival will be evaluated as the time from the diagnosis of the hematological disease at any staging until all-cause death


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
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): NCT05958134


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Brazil
Universidade Federal da Bahia Recruiting
Salvador, Bahia, Brazil, 40110-060
Contact: Daniela da Silva Leal Diniz       Daniela.Diniz@ebserh.gov.br   
Principal Investigator: Maria Almeida Dias         
Ensino e Terapia de Inovação Clinica AMO-ETICA Recruiting
Salvador, Bahia, Brazil, 41950-640
Contact: Ana Beatriz Lafaiete       anabeatrizsantos@clinicaamo.com.br   
Principal Investigator: Marianna Batista         
Instituto Mário Penna - Ensino Pesquisa e Inovação Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30380-472
Contact: Cintia Maria de Lima       cintia.lima@mariopenna.org.br   
Principal Investigator: Frederico Nogueira         
Instituto de Medicina Integral Professor Fernando Figueira - IMIP Recruiting
Recife, Pernambuco, Brazil, 50070-902
Contact: Laise Xavier       pesquisaclinica@imip.org.br   
Principal Investigator: Andrea Lopes         
Centro de Pesquisas Oncológicas - CEPON Not yet recruiting
Florianópolis, Santa Catarina, Brazil, 88034-000
Contact: Hanalydia de Melo Machado       hanalydia.machado@cepon.org.br   
Principal Investigator: David Ferreira         
Hospital Universitário de Botucatu Recruiting
Botucatu, São Paulo, Brazil, 18618-686
Contact: André Luís Bertani       andre.bertani@unesp.br   
Principal Investigator: Rafael Gaiolla         
Instituto Nacional de Câncer - INCA Not yet recruiting
Rio De Janeiro, Brazil, 20230-130
Contact: Cecilia de Melo Borba Mathias dos Santos       cecilia.melo@inca.gov.br   
Principal Investigator: Ricardo Bigni         
Hospital Municipal da Vila Santa Catarina Recruiting
São Paulo, Brazil, 04378-500
Contact: Carolina Feres       carolferes@gmail.com   
Principal Investigator: Larissa Lane Cardoso Teixeira         
Hospital Israelita Albert Einstein Recruiting
São Paulo, Brazil, 05652-900
Contact: Juliana Dall Agnol Da Rocha       juliana.dall@einstein.br   
Principal Investigator: Guilherme Fleury Perini         
AC Camargo Câncer Center Recruiting
São Paulo, Brazil, 1509-001
Contact: Tatiana Iafuso       tatiana.iafuso@accamargo.org.br   
Principal Investigator: Talita Silveira         
Sponsors and Collaborators
AstraZeneca
Hospital Israelita Albert Einstein
Investigators
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Principal Investigator: Guilherme Fleury Perini Hospital Israelita Albert Einstein
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05958134    
Other Study ID Numbers: D133HR00022
BRA-DLBCL ( Other Identifier: Hospital Israelita Albert Einstein )
First Posted: July 24, 2023    Key Record Dates
Last Update Posted: May 7, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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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 AstraZeneca:
Lymphoma; RWE; Diffuse Large B Cell
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