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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 23
- Primary Endpoint
- Progression Free Survival (PFS) as Assessed by Investigator
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
HL Participants: BV Consolidation Treatment Post-ASCT
Participants diagnosed with HL who undergone or undergoing post-ASCT BV consolidation treatment will be observed prospectively over 24-month period after treatment cessation.
Intervention: No Intervention (Other)
HL Participants: BV Salvage Pre-ASCT
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.
Intervention: No Intervention (Other)
Outcomes
Primary Outcomes
Progression Free Survival (PFS) as Assessed by Investigator
Time Frame: From initiation of BV treatment post-ASCT until disease progression or relapse, or death (up to 36 months)
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.
Secondary Outcomes
- Overall Survival (OS)(From initiation of BV treatment until death from any cause (up to 36 months))