Suspended

Effectiveness of A+AVD vs ABVD Regimens in Advanced Classical Hodgkin's Lymphoma Patients: A Retrospective, Multicentre, Medical Chart Review Study

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Hemic and Lymphatic Diseases+6

+ Hodgkin Disease

+ Immune System Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 2023
See protocol details

Summary

Principal SponsorTakeda
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 31, 2023

Actual date on which the first participant was enrolled.

This is an observational, multicenter and retrospective study to evaluate the effectiveness of A+AVD regimen compared to ABVD regimen as first-line therapy for the treatment of Brazilian participants with advanced cHL diagnosis. 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).

Official TitleEffectiveness of A+AVD vs ABVD Regimens in Advanced Classical Hodgkin's Lymphoma Patients: A Retrospective, Multicentre, Medical Chart Review Study
NCT06104878
Principal SponsorTakeda
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesHodgkin DiseaseImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic Type

Criteria

3 inclusion criteria required to participate
Histologically confirmed diagnosis of advanced cHL (International Classification of Diseases and Related Health Problems 10th Revision [ICD-10] code C81.X). The diagnosis of cHL will be confirmed according to World Health Organization (WHO) classification. Advanced disease is defined as having the diagnosis at stage IIB, III or IV, based on Ann Arbor classification.
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).
3 exclusion criteria prevent from participating
With previous or concurrent malignancies, except participants with completely excised carcinoma in situ of any type and basal or squamous cell carcinoma of the skin.
Who are simultaneously participating in another study.
Who participated in the ECHELON-1 Clinical Study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

Hospital São Rafael - Instituto D'Or de Pesquisa e Ensino

Salvador, BrazilOpen Hospital São Rafael - Instituto D'Or de Pesquisa e Ensino in Google Maps
Suspended

Instituto D'Or de Pesquisa e Ensino

Brasília, Brazil
Suspended

Oncoclinicas Rio de Janeiro S.A

Rio de Janeiro, Brazil
Suspended

Beneficência Portuguesa de São Paulo - Real Benemerita Associação Portuguesa de Beneficência

São Paulo, Brazil
Suspended6 Study Centers