Hodgkin LymphomaBV-MAZOVIANCT05100056
A Study of Brentuximab Vedotin in Adults With Hodgkin's Lymphoma
An observational study of Hodgkin Lymphoma, run by Takeda at 13 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma
- How many people
- 70 participants
- Where
- 13 sitesPoland
- Study dates
- 8 Mar 2022to 13 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Poland13 sites, 13 recruiting
- Recruiting
Uniwersyteckie Centrum Kliniczne, Gdansk
Gdansk, Pomeranian Voivodeship, 80-214
Site Contact, 48 58 349 20 00, info@uck.gda.pl
Jan Zaucha
- Recruiting
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slskiego Uniwersytetu Medycznego w Katowicach
Katowice, Slskie, 40-027
Site Contact, 48 32 256 28 58, klinhem@sum.edu.pl
Ryszard Wichary
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Krakowie
Krakow, Lesser Poland Voivodeship, 31-115
Site Contact, 48 12 63 48 268, kontakt@onkologia.krakow.pl
Monika Dlugosz-Danecka
- Recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, 31-501
Site Contact, 48 12 424 76 32, rejestracja.hematologia@su.krakow.pl
Agnieszka Giza
- Recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii, im. M. Kopernika w Lodzi
Lodz, Łódź Voivodeship, 93-513
Site Contact, 48 42 689 50 00, szpital@kopernik.lodz.pl
Magdalena Witkowska
- Recruiting
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
Lublin, Lublin Voivodeship, 20-090
Site Contact, 48 81 454 1226, cozl@cozl.eu
Marta Morawska
- Recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, 10-228
Site Contact, 48 89 539 81 33, sek.hematologia@poliklinika.net
Edyta Subocz
- Recruiting
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, Greater Poland Voivodeship, 61-848
Site Contact, 48 61 854 93 83, hematologia.sekretariat@skpp.edu.pl
Lidia Gil
- Recruiting
NU-MED Specjalistyczny Szpital Onkologiczny Tomaszow Mazowiecki
Tomaszow Mazowiecki, Masovian Voivodeship, 97-200
Site Contact, 48 44 786 81 00, sekretariat.tomaszow@nu-med.pl
Ewa Chmielowska
- Recruiting
Uniwersyteckie Centrum Kliniczne WUM
Warsaw, Masovian Voivodeship, 02-097
Site Contact, 48 22 599 28 18, kho.csk@uckwum.pl
Joanna Drozd-Sokolowska
- Recruiting
Instytut Hematologii i Transfuzjologii
Warsaw, Masovian Voivodeship, 02-776
Site Contact, 48 22 34 96 334, hemsek@ihit.waw.pl
Agnieszka Kolkowska-Lesniak
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, 02-781
Site Contact, 48 22 546 20 00, klinikachloniakow@pib-nio.pl
Ewa Paszkiewicz-Kozik
- Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Dolnoslskie, 50-556
Site Contact, 48 71 784 25 76, khn@usk.wroc.pl
Tomasz Wrobel
About this study
Official 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
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.
Read the 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.
- Conditions
- Hodgkin Lymphoma
- Being tested
- No Intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No Intervention | |
| 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) as Assessed by Investigator
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.
Measured: From initiation of BV treatment post-ASCT until disease progression or relapse, or death (up to 36 months)
Secondary outcomes (1)
Overall Survival (OS)
OS is defined as the time from initiation of therapy to death from any cause. It will be analyzed using Kaplan-Meier method.
Measured: From initiation of BV treatment until death from any cause (up to 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start8 Mar 2022
- Primary completion13 Jan 2027 (estimated)
- Study completion13 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100056
- Sponsor's protocol ID
- Brentuximab-5018
- Acronym
- BV-MAZOVIA
- Status last verified
- May 2026
- First submitted
- 28 Oct 2021
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05100056
- Acronym / sponsor ID
- BV-MAZOVIA / Brentuximab-5018
- Conditions
- Hodgkin Lymphoma
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 13 Jan 2027 (estimated)
- Study completion
- 13 Jan 2027 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HL Participants: BV Salvage Pre-ASCT | – | Other: No InterventionParticipants 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. |
| HL Participants: BV Consolidation Treatment Post-ASCT | – | Other: No InterventionParticipants diagnosed with HL who undergone or undergoing post-ASCT BV consolidation treatment will be observed prospectively over 24-month period after treatment cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | HL Participants: BV Consolidation Treatment Post-ASCT, HL Participants: BV Salvage Pre-ASCT |
Primary outcome
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.
1 secondary outcome
Overall Survival (OS)
Time frame: From initiation of BV treatment until death from any cause (up to 36 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Hodgkin Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma, run by Takeda at 13 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.