A Study of Brentuximab Vedotin in Adults With Hodgkin's Lymphoma (BV-MAZOVIA)

Takeda

Status: Enrolling

Conditions: Hodgkin Lymphoma

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05100056

Brentuximab-5018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

70 participants in 2 patient groups

HL Participants: BV Salvage Pre-ASCT

Description:

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.

Treatment:

Other: No Intervention

HL Participants: BV Consolidation Treatment Post-ASCT

Description:

Participants diagnosed with HL who undergone or undergoing post-ASCT BV consolidation treatment will be observed prospectively over 24-month period after treatment cessation.

Treatment:

Other: No Intervention