Clinical trial NCT06104878: A Study in Adults With Advanced Classical Hodgkin's Lymphoma (cHL) in Brazil Treated With Brentuximab Vedotin Together With Chemotherapy Compared to Chemotherapy Alone
Official title: Effectiveness of A+AVD vs ABVD Regimens in Advanced Classical Hodgkin's Lymphoma Patients: A Retrospective, Multicentre, Medical Chart Review Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hodgkin Lymphoma
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed of advanced cHL treated with A+AVD or ABVD as first-line systemic therapy in Brazil.

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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 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:
measure: Overall Survival (OS)
timeFrame: From index date (treatment start date) to death by any cause during the study follow-up period (up to 5.5 years)
measure: Number of Participants Stratified by Vital Status on Last Follow up Visit
timeFrame: Up to approximately 5 years (Follow-up Period)
measure: Number of Deaths and Cause of Deaths
timeFrame: Up to approximately 5.5 years
measure: Time to Next Treatment (TTNT)
timeFrame: From the date of initiation of a treatment to the date of commencement of the next line of therapy (up to 5.5 years)
measure: Treatment-Free-Interval (TFI)
timeFrame: Up to approximately 5.5 years
measure: Number of Participants With Serious Adverse Events (SAEs) During Follow-up Period
timeFrame: Up to approximately 5 years (Follow-up Period)
measure: Number of Participants With Adverse Events (AEs) During follow-up Period
timeFrame: Up to approximately 5 years (Follow-up Period)
measure: Number of Participants With AEs Leading to Drug Discontinuation or Dose Reduction During Follow-up Period
timeFrame: Up to approximately 5 years (Follow-up Period)
measure: Number of Participants With Most Common SAEs and Total AEs During Follow-up Period
timeFrame: Up to approximately 5 years (Follow-up Period)
measure: Number of Treatment Cycles Participants Received
timeFrame: Up to approximately 6 months
measure: Percentage of Participants With Completed Treatment Cycles
timeFrame: Up to approximately 6 months
measure: Number of Participants With Treatment Interruption and Main Reasons
timeFrame: Up to approximately 6 months
measure: Number of Participants With Comorbidities and Comorbidities per Type
timeFrame: Up to approximately 5.5 years
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital São Rafael - Instituto D'Or de Pesquisa e Ensino
state: Bahia
city: Brasilia
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino
state: Distrito Federal
city: Rio de Janeiro
country: Brazil
facility: Oncoclinicas Rio de Janeiro S.A
city: Sao Paulo
country: Brazil
facility: Beneficência Portuguesa de São Paulo - Real Benemerita Associação Portuguesa de Beneficência
city: Sao Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz - HAOC
city: Sao Paulo
country: Brazil
facility: AC Camargo Cancer Center / Fundação Antonio Prudente Liberdade
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: