A Study of Brentuximab Vedotin in Adults With Hodgkin's Lymphoma

Study Overview
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Brief Summary
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The main aim is to check how effective BV is for treating adults with HL. Study medication will be prescribed according to the clinic's standard practice. Participants will visit the study clinic 5 times, once every 12 weeks. When study treatment has completed, a follow-up visit will be scheduled every 3 months during the first year and every 4-6 months during the next year.

Detailed Description
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This is a prospective, observational study in participants with HL who underwent or are candidates for ASCT and receiving or will receive the standard treatment of BV. This study will assess the safety profile and effectiveness of BV in pre and post-ASCT in the real-world clinical practice. The study will enroll approximately 70 participants. The data will be collected and recorded in electronic case report forms (e-CRFs) in scope of National Drug Program (NDP). All the participants will be assigned to two observational cohorts: HL Participants: BV Salvage Pre-ASCT HL Participants: BV Consolidation Treatment Post-ASCT This multi-center trial will be conducted in Poland. All participants will be followed up for 24 months. The overall duration of the study will be approximately 4.5 years.

Official Title
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Effectiveness and Safety of Consolidative Brentuximab Vedotin (BV) Treatment Administered to Hodgkin's Lymphoma (HL) Patients That Had Undergone Autologous Stem Cell Transplant (ASCT). Prospective, Multicenter, Observational Study

Conditions
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Hodgkin Lymphoma

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Adult participant (aged greater than or equal to [>=18] years) that underwent or are candidates for ASCT and were enrolled in BV HL NDP receiving treatment according to the Summary of Product Characteristics for Adcetris and NDP. Exclusion Criteria: Currently participates or plans to participate in any interventional clinical trial. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

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 |
| --- | --- |
| HL Participants: BV Salvage Pre-ASCT<br>Participants diagnosed with HL who undergone or undergoing pre-ASCT BV salvage and continue with post-ASCT treatment will be observed prospectively over 24-month period after treatment cessation. | Other: No Intervention<br>* This is a non-interventional study.<br>|
| HL Participants: BV Consolidation Treatment Post-ASCT<br>Participants diagnosed with HL who undergone or undergoing post-ASCT BV consolidation treatment will be observed prospectively over 24-month period after treatment cessation. | Other: No Intervention<br>* This is a non-interventional study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) as Assessed by Investigator | PFS will be assessed by investigator and defined as the time from the first dose of BV post ASCT until the first occurrence of disease progression or relapse, or death for any reason. Disease progression is at least a 50 percent (%) increase in the size of lesions, or the occurrence of new lesions. It will be analyzed using Kaplan-Meier method. | From initiation of BV treatment post-ASCT until disease progression or relapse, or death (up to 36 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is defined as the time from initiation of therapy to death from any cause. It will be analyzed using Kaplan-Meier method. | From initiation of BV treatment until death from any cause (up to 36 months) | 

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