A Study in Adults With Advanced Classical Hodgkin's Lymphoma (cHL) in Brazil Treated With Brentuximab Vedotin Together With Chemotherapy Compared to Chemotherapy Alone
Key facts
- Who runs it
- Takeda
- Where
- Brazil6 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 31 Dec 2023
- Ended
- 31 Oct 2024
- Type of study
- Observational, 2 groups
- Record updated
- 6 March 2024
- Why it stopped
- Company decision after projects re-evaluation, taken before the study initiation
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
The 2 groups in the trial
- 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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effectiveness of A+AVD vs ABVD Regimens in Advanced Classical Hodgkin's Lymphoma Patients: A Retrospective, Multicentre, Medical Chart Review Study
- Record updated
- 6 March 2024