KLIO - Non-interventional Multicenter Prospective and Retrospective Study to Describe Treatment Patterns and Disease Control in Patients With Classical Hodgkin's Lymphoma (cHL) and Systemic Anaplastic Large Cell Lymphoma (sALCL) in Routine Clinical Practice in the Russian Federation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 50
- 主要终点
- Description of Treatment Patterns Used for cHL or sALCL
研究概览
简要总结
The purpose of this study is to describe patterns of treatment used for cHL and sALCL in real world setting.
详细描述
This is a non-interventional, prospective and retrospective study of participants with cHL and sALCL. The study will collect information on therapy and outcome of cHL and sALCL in real-life clinical practice.
The study will enroll approximately 2000 participants. Based on the diagnosis of the disease, participants will be assigned to one of the following groups:
- Newly Diagnosed and RR cHL Participants
- Newly Diagnosed and RR sALCL Participants
This multi-center trial will be conducted in Russia. The retrospective data will be collected for the participants with RR cHL or RR sALCL at the time of enrollment and for participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study at Visit 1 (Baseline). The prospective data will be collected for a period of 2 years from Visit 1 (Baseline) to Visit 5 (Month 24, Final Visit), both for newly diagnosed participants with cHL or sALCL and participants with RR cHL or RR sALCL at the time of enrolment, and participants with RR cHL or RR sALCL within 3 years prior to inclusion in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Male and female participants 18 years or older by the time of enrollment.
- •Histologically confirmed diagnosis of cHL or sALCL.
- •Newly diagnosed participants, or participants with RR cHL or RR sALCL at the time of enrollment, or participants with RR cHL or RR sALCL within 3 years prior to inclusion in the Study.
排除标准
- •Unconfirmed diagnosis of cHL or sALCL.
- •Current, previous (within the last 3 years) or planned (for the next 2 years) participation in interventional clinical trials.
- •Participation in the non-interventional study CHL-5001 "An international, multi-centre, non-interventional retrospective study to describe treatment pathways, outcomes, and resource use in participants with classical Hodgkin lymphoma (B-HOLISTIC)" (Sponsor is Takeda Pharmaceuticals International AG).
- •Participants for whom the minimum study dataset was not available from their hospital medical records.
结局指标
主要结局
Description of Treatment Patterns Used for cHL or sALCL
时间窗: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants Receiving Various Chemotherapy Regimens
时间窗: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Were Eligible for AutoSCT did not Receive it (Including Reasons)
时间窗: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Pre-SCT Therapy Regimens
时间窗: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of Relapse/Refractory (RR) Treatment Patterns
时间窗: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Received Chemotherapy Regimens as per National Guidelines
时间窗: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Received Radiotherapy Including Site (Extended/Involved) and Total Dosing
时间窗: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Received Autologous Stem Cell Transplantation (AutoSCT)
时间窗: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Percentage of Participants who Received Allogeneic Stem Cell Transplantation (AlloSCT)
时间窗: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
Distribution of First Line Treatment Patterns According to Prognostic Group
时间窗: From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years)
次要结局
- Disease Free Survival-1 (DSF1)(From date of complete remission after first line of therapy up to relapse or till the latest date of participant observed (up to Month 24))
- Overall Survival (OS)(From the date of cHL or sALCL diagnosis confirmation until the date of death from any cause or till the latest date of participant observed (up to Month 24))
- Freedom From Treatment Failure-1 (FFTF1)(From date of initiation first therapy until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till observed (up to Month 24))
- Percentage of Participants with Complete Remission (CR) Achieved by the end of Treatment Regimen(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Percentage of Participants With Partial Remission (PR) Achieved by the end of Treatment Regimen(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Event Free Survival-1 (EFS1)(From date of initiation first therapy until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24))
- Percentage of Participants With Progression Disease (PD) While on the Treatment(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Percentage of Participants With Relapse (Both Early [<12 Months After the end of First Line Treatment] and Late Relapses)(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Percentage of Participants With Primary Resistance(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Percentage of Participants With Overall Response Achieved by the end of Treatment Regimen(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Percentage of Participants With Stable Disease (SD) Achieved by the end of Treatment Regimen(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Percentage of Resistant Participants to the Second and Later Treatment Lines(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Percentage of Participants in Whom Brentuximab Vedotin was Used(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Distribution of Treatment Patterns Containing Brentuximab Vedotin in Clinical Practice(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Disease Free Survival (DFS) After the Treatment Line Including Brentuximab Vedotin Based on the Number of Cycles of Brentuximab Vedotin Performed Within this Treatment Line(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Percentage of Participants With CR Achieved to the end of the Given Treatment Regimen Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Distribution of Clinical Variables for cHL and sALCL at the Time of Resistance/Relapses(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Percentage of Participants for Whom PET and PET/Computed Tomography (CT) was Used for Primary Disease Diagnostic and Staging(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Percentage of Participants for Whom PET and PET/CT Scan was Used for Interim Treatment Response Evaluation(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- OS Based on use of PET/CT Scan for Initial Disease Staging, Interim and Final Response Assessment During Frontline and Second Line Treatment(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Timepoint of Performing Interim Response Evaluation With PET/CT Scan (Number of Cycle After Which the Evaluation is Performed, Time From the Start of Last Cycle of Therapy)(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- FFTF Based on the Number of Cycles of Brentuximab Vedotin Performed Within the Treatment Line(From initiation therapy date until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complication, death from any cause, or till observed (up to Month 24))
- EFS Based on the Number of Cycles of Brentuximab Vedotin Performed Within this Treatment Line(From initiation therapy date until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24))
- Percentage of Participants With Overall Response Achieved to the end of the Given Treatment Regimen Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Distribution of Clinical Variables for cHL and sALCL at the Time of Primary Diagnosis(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Distribution of Imaging Patterns Used for Disease Control of the Participants Being in Remission(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Event Free Survival-2 (EFS2)(From date of initiation second therapy until therapy discontinuation, not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till observed (up to Month 24))
- Percentage of Participants With Progressive Disease Developed While on the Treatment Regimen Including Brentuximab Vedotin Achieved Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Number of Cycles of Brentuximab Vedotin Before and After Stem Cell Transplantation (SCT)(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Percentage of Participants for Whom PET and PET/CT Scan Were Used to Evaluate Final Treatment Response(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Timepoint of Performing Final Response Evaluation With PET/CT scan (Number of Cycle After Which the Evaluation is Performed, Time From the Start of Last Cycle of Therapy)(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Time of Performing PET and PET/CT Scan After SCT(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Distribution of Imaging Patterns Used for Primary Disease Diagnostic and Staging in Different Regions of Russia(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Percentage of cHL or sALCL Participants who Used Healthcare Resources: Hospitalizations, Sick Leave Sheet(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Distribution of Imaging Patterns Used for Treatment Response Evaluation(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Number of Hospitalizations(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Number of Days Spent on Hospital Beds(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Number of Sick Leaves(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Number of Days Spent on Sick Leaves(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))
- Disease Free Survival-2 (DSF2)(From date of complete remission after second line of therapy up to relapse or till the latest date of participant observed (up to Month 24))
- Freedom From Treatment Failure-2 (FFTF2)(From date of initiation second therapy until any treatment failures such as disease progression, not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till observed (up to Month 24))
- Number of Cycles of Brentuximub Vedotin Administered in Routine Clinical Practice(From frontline treatment for newly diagnosed participants or within 3 years prior to inclusion in the study for RR cHL or RR sALCL participants till end of participant observation in scope of the study (approximately 5 years))