A Study in Adults With Advanced Classical Hodgkin's Lymphoma (cHL) in Brazil Treated With Brentuximab Vedotin Together With Chemotherapy Compared to Chemotherapy Alone

Takeda

Status: Withdrawn

Conditions: Hodgkin Lymphoma

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06104878

Brentuximab-5021

Details and patient eligibility

About

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.

Full description

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

0 participants in 2 patient groups

ABVD: Doxorubicin 25 mg/m^2 + Bleomycin 15 mg + Vinblastine 6 mg/m^2 + Dacarbazine 375 mg/m^2

Description:

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.

Treatment:

Other: No Intervention

A+AVD: Brentuximab Vedotin 1.2mg/kg+Doxorubicin 25mg/m^2 +Vinblastine 6mg/m^2 +Dacarbazine 375mg/m^2

Description:

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.

Treatment:

Other: No Intervention