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

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05958134
• Other study ID #: D133HR00022
• Secondary ID: BRA-DLBCL
• Status: Recruiting
• Start date: July 15, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Brazil	Instituto Mário Penna - Ensino Pesquisa e Inovação	Belo Horizonte	Minas Gerais
Brazil	Hospital Universitário de Botucatu	Botucatu	São Paulo
Brazil	Centro de Pesquisas Oncológicas - CEPON	Florianópolis	Santa Catarina
Brazil	Instituto de Medicina Integral Professor Fernando Figueira - IMIP	Recife	Pernambuco
Brazil	Instituto Nacional de Câncer - INCA	Rio De Janeiro
Brazil	Ensino e Terapia de Inovação Clinica AMO-ETICA	Salvador	Bahia
Brazil	Universidade Federal da Bahia	Salvador	Bahia
Brazil	AC Camargo Câncer Center	São Paulo
Brazil	Hospital Israelita Albert Einstein	São Paulo
Brazil	Hospital Municipal da Vila Santa Catarina	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)