Hodgkin Lymphoma
Conditions
Keywords
Drug Therapy
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.
Interventions
OTHERNo Intervention
This is a non-interventional study.
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
1. Currently participates or plans to participate in any interventional clinical trial. 2. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) as Assessed by Investigator | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From initiation of BV treatment until death from any cause (up to 36 months) | OS is defined as the time from initiation of therapy to death from any cause. It will be analyzed using Kaplan-Meier method. |
Countries
Poland
Contacts
CONTACTTakeda Contact
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed