A Study in Adults With Advanced Classical Hodgkin's Lymphoma (cHL) in Brazil Treated With Brentuximab Vedotin Together With Chemotherapy Compared to Chemotherapy Alone
NCT ID: NCT06104878
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2023-12-31
2024-10-31
Brief Summary
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A+AVD includes Brentuximab Vedotin + Doxorubicin + Vinblastine + Dacarbazine; ABVD includes Doxorubicin + Bleomycin + Vinblastine + Dacarbazine.
The study will be conducted by reviewing and collecting already existing medical records.
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Detailed Description
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The study will enroll approximately 200 participants who were treated with A+AVD or ABVD as first line therapy for at least one full cycle of 28 days, from July 1st, 2017, to December 31st, 2020. Participants will be identified from medical charts and will be assigned into following treatment groups:
* ABVD: Doxorubicin 25 milligrams per square meter (mg/m\^2) + Bleomycin 15 milligram (mg) + Vinblastine 6 mg/m\^2 + Dacarbazine 375 mg/m\^2
* A+AVD: Brentuximab Vedotin 1.2 milligrams per kilogram (mg/kg) + Doxorubicin 25 mg/m\^2 + Vinblastine 6 mg/m\^2 + Dacarbazine 375 mg/m\^2
This multi-center trial will be conducted in Brazil. The duration of the study will be 12 months. Participants will be followed up for at least 2 years after the last therapy cycle (treatment window considered for the study from July 1st, 2017, to December 31st, 2020).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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ABVD: Doxorubicin 25 mg/m^2 + Bleomycin 15 mg + Vinblastine 6 mg/m^2 + Dacarbazine 375 mg/m^2
Participants treated with doxorubicin 25 mg/m\^2, bleomycin 15 mg, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 as first line therapy in each 28-day cycle for up to 6 cycles from July 1st, 2017, to December 31st, 2020, will be observed retrospectively.
No Intervention
No Intervention will be administered in this study.
A+AVD: Brentuximab Vedotin 1.2mg/kg+Doxorubicin 25mg/m^2 +Vinblastine 6mg/m^2 +Dacarbazine 375mg/m^2
Participants treated with brentuximab vedotin 1.2 mg/kg, doxorubicin 25 mg/m\^2, vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2 as first line therapy in each 28-day cycle for up to 6 cycles from July 1st, 2017, to December 31st, 2020, will be observed retrospectively.
No Intervention
No Intervention will be administered in this study.
Interventions
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No Intervention
No Intervention will be administered in this study.
Eligibility Criteria
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Inclusion Criteria
* Who received at least one full cycle of A+AVD or ABVD regimen as first-line treatment (first systemic therapy for cHL management; systemic therapy naïve participants) from July, 1st 2017 to December, 31st 2020; and who completed the 6-cycle treatment until the end of December 2020.
* At least 2 years of retrospective information from the index date (treatment window) and at least 2 years of follow-up (after the end of treatment).
Exclusion Criteria
* Who are simultaneously participating in another study.
* Who participated in the ECHELON-1 Clinical Study.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Hospital São Rafael - Instituto D'Or de Pesquisa e Ensino
Salvador, Estado de Bahia, Brazil
Instituto D'Or de Pesquisa e Ensino
Brasília, Federal District, Brazil
Oncoclinicas Rio de Janeiro S.A
Rio de Janeiro, , Brazil
Beneficência Portuguesa de São Paulo - Real Benemerita Associação Portuguesa de Beneficência
São Paulo, , Brazil
Hospital Alemão Oswaldo Cruz - HAOC
São Paulo, , Brazil
AC Camargo Cancer Center / Fundação Antonio Prudente Liberdade
São Paulo, , Brazil
Countries
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Related Links
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To obtain more information on the study, click this link.
Other Identifiers
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Brentuximab-5021
Identifier Type: -
Identifier Source: org_study_id
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