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.
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).
Study Type
OBSERVATIONAL
No Intervention will be administered in this study.
Hospital São Rafael - Instituto D'Or de Pesquisa e Ensino
Salvador, Estado de Bahia, Brazil
Instituto D'Or de Pesquisa e Ensino
Brasília, Federal District, Brazil
Oncoclinicas Rio de Janeiro S.A
Rio de Janeiro, Brazil
Beneficência Portuguesa de São Paulo - Real Benemerita Associação Portuguesa de Beneficência
São Paulo, Brazil
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.
Time frame: 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)
Overall Survival (OS)
The OS is defined as time from index date (treatment start date) to death by any cause during the study follow-up period.
Time frame: 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
Latest information about participants vital status (alive, death, lost of follow-up) will be reported.
Time frame: Up to approximately 5 years (Follow-up Period)
Number of Deaths and Cause of Deaths
Number of deaths and different cause of deaths will be reported.
Time frame: Up to approximately 5.5 years
Time to Next Treatment (TTNT)
The TTNT is defined as interval from the date of initiation of a treatment to the date of commencement of the next line of therapy.
Time frame: 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)
The TFI is defined as interval between the end of one regimen and the start of the next regimen (death or the end of follow-up are censoring events).
Time frame: Up to approximately 5.5 years
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Hospital Alemão Oswaldo Cruz - HAOC
São Paulo, Brazil
AC Camargo Cancer Center / Fundação Antonio Prudente Liberdade
São Paulo, Brazil
Number of Participants With Serious Adverse Events (SAEs) During Follow-up Period
A SAE is defined as signs, symptoms or outcomes which results in death, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event.
Time frame: Up to approximately 5 years (Follow-up Period)
Number of Participants With Adverse Events (AEs) During follow-up Period
An adverse event (AE) is any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product (including peripheral neuropathy and neutropenia).
Time frame: Up to approximately 5 years (Follow-up Period)
Number of Participants With AEs Leading to Drug Discontinuation or Dose Reduction During Follow-up Period
An AE is any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.
Time frame: Up to approximately 5 years (Follow-up Period)
Number of Participants With Most Common SAEs and Total AEs During Follow-up Period
A SAE is defined as signs, symptoms or outcomes which results in death, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event. Most common SAEs are defined as most frequent SAEs occurred during the study. An AE is any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.
Time frame: Up to approximately 5 years (Follow-up Period)
Number of Treatment Cycles Participants Received
Number of treatment cycles received by participants will be reported. The length of each treatment cycle will be 28 days.
Time frame: Up to approximately 6 months
Percentage of Participants With Completed Treatment Cycles
Participant who completed 6 cycles of treatment during the treatment window (July 1, 2017, to December 31, 2020) will be considered completed. The length of each treatment cycle will be 28 days.
Time frame: Up to approximately 6 months
Number of Participants With Treatment Interruption and Main Reasons
Number of participant's that interrupted their treatment and the main reason will be reported. Reasons includes economical (example, healthcare insurance issues, cost-related, access barriers, etc.), participant's decision, adverse event (including toxicity), diseases progression, medical decision, death, other.
Time frame: Up to approximately 6 months
Number of Participants With Comorbidities and Comorbidities per Type
Comorbidities may include diabetes, obesity, autoimmune disease (example, arthritis, lupus and others), infectious disease (example, human immunodeficiency virus, Epstein Barr virus), cardiovascular disease (example, congestive heart failure, rhythm abnormalities, hypertension), dyslipidemia, cerebrovascular disease, gastrointestinal disease (example, gastritis, ulcer), pulmonary disease (example, chronic pulmonary disease, chronic obstructive disease), liver disease, renal disease, thyroid disease, depression, neurologic (example neuropathies), other cancers, and others.
Time frame: Up to approximately 5.5 years