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NCT Number: NCT05100056

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

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.

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroclaw, Dolnoslskie, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

  1. 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

  1. Overall Survival (OS)

    Time frame: 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.

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Acronym: BV-MAZOVIA

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 29, 2021
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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