Evaluating Brentuximab Vedotin for Adults with Hodgkin's Lymphoma
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
Run by Takeda · NCT05100056 · Data updated 2026-11-12
This study is testing how well Brentuximab Vedotin works and how safe it is for adults with Hodgkin's Lymphoma who are getting or preparing for a stem cell transplant.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Takeda Industry-sponsored |
| Locations | 13 sites (Wroclaw, Dolnoslskie and 12 other locations) |
| Status | Recruiting |
| Started | March 8, 2022 |
| Main results expected | January 13, 2027 |
| Study ends | January 13, 2027 |
| Registry record updated | May 27, 2026 |
| Trial ID | NCT05100056 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have undergone or are candidates for ASCT and are receiving treatment with Brentuximab Vedotin.
✕Probably not a fit
Patients currently participating in other interventional clinical trials may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the effectiveness and safety of Brentuximab Vedotin (BV) in adults with Hodgkin's Lymphoma (HL) who are undergoing or are candidates for autologous stem cell transplantation (ASCT). Participants will receive BV as part of their standard treatment and will be monitored through regular clinic visits over a period of 24 months. The study will enroll approximately 70 participants and will collect data on their treatment outcomes in a real-world clinical setting. Participants will be divided into two cohorts based on their treatment phase: pre-ASCT and post-ASCT.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of BV in improving treatment outcomes for adults with Hodgkin's Lymphoma.
How similar studies have gone: Previous studies have shown promising results with Brentuximab Vedotin in treating Hodgkin's Lymphoma, indicating that this approach is supported by existing evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Dolnoslskie, Poland Recruiting -
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, Greater Poland Voivodeship, Poland Recruiting -
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Krakowie
Krakow, Lesser Poland Voivodeship, Poland Recruiting -
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, Poland Recruiting -
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
Lublin, Lublin Voivodeship, Poland Recruiting -
NU-MED Specjalistyczny Szpital Onkologiczny Tomaszow Mazowiecki
Tomaszow Mazowiecki, Masovian Voivodeship, Poland Recruiting
Show 7 more locations
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Uniwersyteckie Centrum Kliniczne WUM
Warsaw, Masovian Voivodeship, Poland Recruiting -
Instytut Hematologii i Transfuzjologii
Warsaw, Masovian Voivodeship, Poland Recruiting -
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, Poland Recruiting -
Uniwersyteckie Centrum Kliniczne, Gdansk
Gdansk, Pomeranian Voivodeship, Poland Recruiting -
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slskiego Uniwersytetu Medycznego w Katowicach
Katowice, Slskie, Poland Recruiting -
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, Poland Recruiting -
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii, im. M. Kopernika w Lodzi
Lodz, Łódź Voivodeship, Poland Recruiting
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.