Effectiveness of A+AVD vs ABVD Regimens in Advanced Classical Hodgkin's Lymphoma Patients: A Retrospective, Multicentre, Medical Chart Review Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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).
排除标准
- •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.
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 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)
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.
次要结局
- Number of Participants Stratified by Vital Status on Last Follow up Visit(Up to approximately 5 years (Follow-up Period))
- Number of Treatment Cycles Participants Received(Up to approximately 6 months)
- Number of Deaths and Cause of Deaths(Up to approximately 5.5 years)
- Number of Participants With Serious Adverse Events (SAEs) During Follow-up Period(Up to approximately 5 years (Follow-up Period))
- Number of Participants With Adverse Events (AEs) During follow-up Period(Up to approximately 5 years (Follow-up Period))
- Number of Participants With AEs Leading to Drug Discontinuation or Dose Reduction During Follow-up Period(Up to approximately 5 years (Follow-up Period))
- Number of Participants With Most Common SAEs and Total AEs During Follow-up Period(Up to approximately 5 years (Follow-up Period))
- Number of Participants With Treatment Interruption and Main Reasons(Up to approximately 6 months)
- Number of Participants With Comorbidities and Comorbidities per Type(Up to approximately 5.5 years)
- 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))
- 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))
- Percentage of Participants With Completed Treatment Cycles(Up to approximately 6 months)
- Treatment-Free-Interval (TFI)(Up to approximately 5.5 years)