A Study to Describe Treatment Patterns and Disease Control in Participants With cHL and sALCL in Routine Clinical Practice in the Russian Federation

Study Overview
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Brief Summary
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The purpose of this study is to describe patterns of treatment used for cHL and sALCL in real world setting.

Detailed Description
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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.

Official Title
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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

Conditions
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Hodgkin Disease, Lymphoma, Large-cell, Anaplastic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly Diagnosed and RR cHL Participants<br>Participants diagnosed with RR cHL at the time of enrollment and RR cHL within 3 years prior to inclusion in the study will be observed retrospectively. Participants with newly diagnosed cHL, or RR cHL at the time of enrolment, or RR cHL within 3 years prior to inclusion in the study will be observed prospectively for a period of 2 years. Data will be collected from 50 investigational sites to collect information on various treatment options, real-world effectiveness, outcomes and safety within the routine clinical setting. | |
| Newly Diagnosed and RR sALCL Participants<br>Participants diagnosed with RR sALCL at the time of enrollment and RR sALCL within 3 years prior to inclusion in the study will be observed retrospectively. Participants with newly diagnosed sALCL, or RR sALCL at the time of enrolment, or RR sALCL within 3 years prior to inclusion in the study will be observed prospectively for a period of 2 years. Data will be collected from 50 investigational sites to collect information on various treatment options, real-world effectiveness, outcomes and safety within the routine clinical setting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of Treatment Patterns Used for cHL or sALCL |  | 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 |  | 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 |  | 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 |  | 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) |  | 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) |  | 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) |  | 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 |  | 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 |  | 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 |  | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is defined as the time passed 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. | 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) | 
| Disease Free Survival-1 (DSF1) | DFS1 is defined as the time from the date of complete remission after first line of therapy till relapse or till the latest date of participant observed. | 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) | 
| Freedom From Treatment Failure-1 (FFTF1) | FFTF1 is defined as the time passed from date of initiation first therapy until any treatment failures such as disease progression, do not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till the latest date of participant observed. | 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) | 
| Event Free Survival-1 (EFS1) | EFS-1 is defined as the time passed from date of initiation first line therapy until any events such as discontinuation of therapy for any reasons, do not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till the latest date of participant observed. | 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 Complete Remission (CR) Achieved by the end of Treatment Regimen | CR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 is defined as complete disappearance of all target lesions and all nodes with long axis less than (<) 10 millimeter (mm). | 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 | PR based on RECIST 1.1 is defined as greater than or equal to (>=) 30 percent (%) decrease in the sum of longest diameters (SLD) of target lesions but not a CR. CR is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm. | 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 | Overall response based on RECIST 1.1 is defined as the percentage of participants who have a PR or CR to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity. PR is defined as >=30% decrease in the SLD of target lesions but not a CR. CR is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm. | 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 | SD based on RECIST 1.1 is defined as changes in the SLD of targeted lesions ranging between reduction of <10% to an increase by <20% without the appearance of a new lesion, and irrespective of positron emission tomography (PET) results. | 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 Progression Disease (PD) While on the Treatment | PD based on RECIST 1.1 is defined as >20% increase in the SLD of target lesions. For small lymph nodes measuring <15 mm post therapy, a minimum absolute increase of 5 mm and the long diameter should exceed 15 mm. | 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 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 | DFS will be assessed after the treatment line including brentuximab vedotin based on the number of cycles of brentuximab vedotin performed within this Treatment Line. DFS is defined as the time from the date of complete remission till relapse or till the latest date of participant observed. | 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 | FFTF will be assessed based on the number of cycles of brentuximab vedotin performed within this treatment line. FFTF is defined as the time passed from date of initiation therapy until any treatment failures such as disease progression, do not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till the latest date of participant observed. | 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 | EFS will be assessed based on the number cycles of brentuximab vedotin performed within this treatment line. EFS is defined as the time passed from date of initiation therapy until any events such as discontinuation of therapy for any reasons, do not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till the latest date of participant observed. | 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 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 | CR based on RECIST 1.1 is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm. | 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 to the end of the Given Treatment Regimen Based on the Number of the Cycles of Brentuximab Vedotin Performed Within This Treatment Line | Overall response is defined as the percentage of participants who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity. PR is defined as >=30 % decrease in the SLD of target lesions but not a CR. CR is defined as complete disappearance of all target lesions and all nodes with long axis <10 mm. | 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 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 | PD based on RECIST 1.1 is defined as >20% increase in the SLD of target lesions. For small lymph nodes measuring <15 mm post therapy, a minimum absolute increase of 5 mm and the long diameter should exceed 15 mm. | 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) | 
| Distribution of Clinical Variables for cHL and sALCL at the Time of Primary Diagnosis | Clinical variable will include stage, histological types, immunohistochemistry data (yes/no), ALK-status (negative/positive), prognostic groups, prognostic risk factors (International Prognostic Score (IPS), International Prognostic Index, Age-adjusted International Prognostic Index, International T-cell Lymphoma Project Score, Prognostic Index for peripheral T-cell lymphoma unspecified [PTCL-U] [PIT]), prognostic risk factors, and risk factors for relapse. | 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 | Clinical variable will include stage, histological types, immunohistochemistry data (yes/no) and ALK-status (negative/positive). | 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 | OS is defined as the time passed from the date of initiation of cHL or sALCL treatment until the date of death from any cause or till the latest date of participant observed. OS will be analyzed by Cox regression. | 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) | Timepoints will include number of cycle after which the evaluation is performed and 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) | 
| 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) | Timepoints will include number of cycle after which the evaluation is performed and 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) | 
| 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) | 
| 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) | 
| Percentage of cHL or sALCL Participants who Used Healthcare Resources: Hospitalizations, Sick Leave Sheet | Healthcare resources will include hospitalizations and 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) | 
| 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) | DFS2 is defined as the time from the date of complete remission after second line of therapy till relapse or till the latest date of participant observed. | 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) | FFTF2 is defined as the time passed from date of initiation second line therapy until any treatment failures such as disease progression, do not achieving complete remission after therapy, relapse, discontinuation of therapy for complications, death from any cause or till the latest date of participant observed. | 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) | 
| Event Free Survival-2 (EFS2) | EFS-2 is defined as the time passed from date of initiation second line therapy until any events such as discontinuation of therapy for any reasons, do not achieving complete remission after therapy, progression, relapse, death from any cause, late therapy complications including second malignancies or till the latest date of participant observed. | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy