Actively Recruiting
Effectiveness and Safety of Brentuximab Vedotin Treatment for Hodgkin's Lymphoma Patients Before and After Autologous Stem Cell Transplant: Prospective Observational Study
Led by Takeda · Updated on 2026-05-27
70
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well brentuximab vedotin (BV) works for treating adults with Hodgkin lymphoma (HL) who have undergone or are candidates for autologous stem cell transplant (ASCT). This observational study focuses on assessing BV's safety and effectiveness in real-world clinical settings before and after ASCT treatment. Approximately 70 participants will take part in this multi-center trial conducted in Poland over about 4.5 years. Participants will receive standard treatment with BV according to clinic practice and be assigned to one of two groups: those receiving BV before ASCT as salvage therapy and those receiving BV after ASCT as consolidation therapy. Each participant will be observed prospectively for 24 months following the end of their BV treatment. No experimental interventions are administered as part of this study. Participants will visit the study clinic five times, spaced every 12 weeks during treatment. After treatment ends, follow-up visits will occur every three months during the first year and every four to six months during the second year. Researchers will collect data electronically and monitor progression-free survival and overall survival for up to 36 months to evaluate treatment outcomes and safety.
CONDITIONS
Brief Title
A Study of Brentuximab Vedotin in Adults With Hodgkin's Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participant aged 18 years or older
- Diagnosed with Hodgkin lymphoma
- Have undergone or are a candidate for autologous stem cell transplant
- Enrolled in brentuximab vedotin treatment under the National Drug Program
- Receiving treatment according to approved guidelines
You will not qualify if you...
- Currently participating or planning to participate in any interventional clinical trial
- Considered unsuitable for the study by the investigator for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants diagnosed with Hodgkin lymphoma who are undergoing or have undergone brentuximab vedotin treatment before or after autologous stem cell transplant are observed in real-world clinical practice.
Visits as per routine clinical practice during treatment and follow-up
Duration - 24 months after treatment ends
Participants are followed for up to 24 months after treatment cessation to assess safety and effectiveness outcomes.
Periodic visits as per clinical follow-up
Trial Site Locations
Total: 13 locations
1
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Dolnoslskie, Poland, 50-556
Actively Recruiting
2
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, Greater Poland Voivodeship, Poland, 61-848
Actively Recruiting
3
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Krakowie
Krakow, Lesser Poland Voivodeship, Poland, 31-115
Actively Recruiting
4
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, Poland, 31-501
Actively Recruiting
5
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
Lublin, Lublin Voivodeship, Poland, 20-090
Actively Recruiting
6
NU-MED Specjalistyczny Szpital Onkologiczny Tomaszow Mazowiecki
Tomaszow Mazowiecki, Masovian Voivodeship, Poland, 97-200
Actively Recruiting
7
Uniwersyteckie Centrum Kliniczne WUM
Warsaw, Masovian Voivodeship, Poland, 02-097
Actively Recruiting
8
Instytut Hematologii i Transfuzjologii
Warsaw, Masovian Voivodeship, Poland, 02-776
Actively Recruiting
9
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
10
Uniwersyteckie Centrum Kliniczne, Gdansk
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Actively Recruiting
11
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slskiego Uniwersytetu Medycznego w Katowicach
Katowice, Slskie, Poland, 40-027
Actively Recruiting
12
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-228
Actively Recruiting
13
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii, im. M. Kopernika w Lodzi
Lodz, Łódź Voivodeship, Poland, 93-513
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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