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

NCT ID: NCT05100056

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-08

Study Completion Date

2026-06-01

Brief Summary

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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

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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.

Conditions

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Hodgkin Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No Intervention

Intervention Type OTHER

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.

No Intervention

Intervention Type OTHER

This is a non-interventional study.

Interventions

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No Intervention

This is a non-interventional study.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, Dolnoslskie, Poland

Site Status RECRUITING

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

Poznan, Greater Poland Voivodeship, Poland

Site Status RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

Site Status RECRUITING

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

Site Status RECRUITING

Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

Lublin, Lublin Voivodeship, Poland

Site Status RECRUITING

NU-MED Specjalistyczny Szpital Onkologiczny Tomaszow Mazowiecki

Tomaszow Mazowiecki, Masovian Voivodeship, Poland

Site Status RECRUITING

Uniwersyteckie Centrum Kliniczne WUM

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Instytut Hematologii i Transfuzjologii

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Uniwersyteckie Centrum Kliniczne, Gdansk

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slskiego Uniwersytetu Medycznego w Katowicach

Katowice, Slskie, Poland

Site Status RECRUITING

Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w Olsztynie

Olsztyn, Warmian-Masurian Voivodeship, Poland

Site Status RECRUITING

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii, im. M. Kopernika w Lodzi

Lodz, Łódź Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Takeda Contact

Role: CONTACT

+1-877-825-3327

Facility Contacts

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Site Contact

Role: primary

48 71 784 25 76

Site Contact

Role: primary

48 61 854 93 83

Site Contact

Role: primary

48 12 63 48 268

Site Contact

Role: primary

48 12 424 76 32

Site Contact

Role: primary

48 81 454 1226

Site Contact

Role: primary

48 44 786 81 00

Site Contact

Role: primary

48 22 599 28 18

Site Contact

Role: primary

48 22 34 96 334

Site Contact

Role: primary

48 22 546 20 00

Site Contact

Role: primary

48 58 349 20 00

Site Contact

Role: primary

48 32 256 28 58

Site Contact

Role: primary

48 89 539 81 33

Site Contact

Role: primary

48 42 689 50 00

Related Links

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https://clinicaltrials.takeda.com/study-detail/618310f4eb0e19002afd69ff

To obtain more information on the study, click here/on this link

Other Identifiers

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Brentuximab-5018

Identifier Type: -

Identifier Source: org_study_id

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