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

May 21, 2026 updated by: Takeda

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Dolnoslskie
      • Wroclaw, Dolnoslskie, Poland, 50-556
        • Recruiting
        • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
        • Contact:
        • Principal Investigator:
          • Tomasz Wrobel
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-848
        • Recruiting
        • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
        • Contact:
        • Principal Investigator:
          • Lidia Gil
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-115
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Krakowie
        • Contact:
        • Principal Investigator:
          • Monika Dlugosz-Danecka
      • Krakow, Lesser Poland Voivodeship, Poland, 31-501
        • Recruiting
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
        • Contact:
        • Principal Investigator:
          • Agnieszka Giza
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-090
        • Recruiting
        • Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
        • Contact:
          • Site Contact
          • Phone Number: 48 81 454 1226
          • Email: cozl@cozl.eu
        • Principal Investigator:
          • Marta Morawska
    • Masovian Voivodeship
      • Tomaszow Mazowiecki, Masovian Voivodeship, Poland, 97-200
        • Recruiting
        • NU-MED Specjalistyczny Szpital Onkologiczny Tomaszow Mazowiecki
        • Contact:
        • Principal Investigator:
          • Ewa Chmielowska
      • Warsaw, Masovian Voivodeship, Poland, 02-776
        • Recruiting
        • Instytut Hematologii i Transfuzjologii
        • Contact:
        • Principal Investigator:
          • Agnieszka Kolkowska-Lesniak
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
        • Contact:
        • Principal Investigator:
          • Ewa Paszkiewicz-Kozik
      • Warsaw, Masovian Voivodeship, Poland, 02-097
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne WUM
        • Contact:
        • Principal Investigator:
          • Joanna Drozd-Sokolowska
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne, Gdansk
        • Contact:
        • Principal Investigator:
          • Jan Zaucha
    • Slskie
      • Katowice, Slskie, Poland, 40-027
        • Recruiting
        • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slskiego Uniwersytetu Medycznego w Katowicach
        • Contact:
        • Principal Investigator:
          • Ryszard Wichary
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-228
        • Recruiting
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w Olsztynie
        • Contact:
        • Principal Investigator:
          • Edyta Subocz
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 93-513
        • Recruiting
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii, im. M. Kopernika w Lodzi
        • Contact:
        • Principal Investigator:
          • Magdalena Witkowska

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants diagnosed with HL (previously enrolled in BV HL NDP) who underwent or are candidates for ASCT will be enrolled in this study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No Intervention
This is a non-interventional study.
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.
Other: No Intervention
This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
From initiation of BV treatment until death from any cause (up to 36 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2022

Primary Completion (Estimated)

January 13, 2027

Study Completion (Estimated)

January 13, 2027

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Brentuximab-5018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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