Study Stopped
Company decision after projects re-evaluation, taken before the study initiation
A Study in Adults With Advanced Classical Hodgkin's Lymphoma (cHL) in Brazil Treated With Brentuximab Vedotin Together With Chemotherapy Compared to Chemotherapy Alone
Effectiveness of A+AVD vs ABVD Regimens in Advanced Classical Hodgkin's Lymphoma Patients: A Retrospective, Multicentre, Medical Chart Review Study
1 other identifier
observational
N/A
1 country
6
Brief Summary
The main aim of this study conducted in Brazil is to understand if there is a difference in the length of time that Classical Hodgkin's Lymphoma (cHL) does not grow or spread further (also called progression free survival or PFS), and in the length of time that participants live with cHL if they are treated with Brentuximab Vedotin in combination with chemotherapy (A+AVD) or chemotherapy alone (ABVD). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2023
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2023
CompletedFirst Posted
Study publicly available on registry
October 27, 2023
CompletedStudy Start
First participant enrolled
December 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedMarch 6, 2024
March 1, 2024
10 months
October 23, 2023
March 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
The PFS will be calculated as the time (months) from the index date to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
From the index date (treatment start date) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first (up to 5.5 years)
Secondary Outcomes (13)
Overall Survival (OS)
From index date (treatment start date) to death by any cause during the study follow-up period (up to 5.5 years)
Number of Participants Stratified by Vital Status on Last Follow up Visit
Up to approximately 5 years (Follow-up Period)
Number of Deaths and Cause of Deaths
Up to approximately 5.5 years
Time to Next Treatment (TTNT)
From the date of initiation of a treatment to the date of commencement of the next line of therapy (up to 5.5 years)
Treatment-Free-Interval (TFI)
Up to approximately 5.5 years
- +8 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
No Intervention will be administered in this study.
Eligibility Criteria
Participants diagnosed of advanced cHL treated with A+AVD or ABVD as first-line systemic therapy in Brazil.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (6)
Hospital São Rafael - Instituto D'Or de Pesquisa e Ensino
Salvador, Estado de Bahia, 41253-190, Brazil
Instituto D'Or de Pesquisa e Ensino
Brasília, Federal District, 70390-140, Brazil
Oncoclinicas Rio de Janeiro S.A
Rio de Janeiro, 22250-905, Brazil
Beneficência Portuguesa de São Paulo - Real Benemerita Associação Portuguesa de Beneficência
São Paulo, 01321-001, Brazil
Hospital Alemão Oswaldo Cruz - HAOC
São Paulo, 01327-001, Brazil
AC Camargo Cancer Center / Fundação Antonio Prudente Liberdade
São Paulo, 09015-010, Brazil
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2023
First Posted
October 27, 2023
Study Start
December 31, 2023
Primary Completion
October 31, 2024
Study Completion
October 31, 2024
Last Updated
March 6, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.