Actively Recruiting

Age: 18Years +
All Genders
ID05100056

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Long-term Monitoring

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

Loading map...

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

Similar Trials

A Multicenter Access and Distribution Protocol for Unlicense...

Hematologic Malignancies

Actively Recruiting

142 locations

A Phase 1, Open-Label, Multiple-Ascending Dose Study of the ...

Non Small Cell Lung Cancer

Actively Recruiting

9 locations

A Phase I Study to Evaluate the Safety and Tolerability of J...

Advanced Solid Tumor (Phase 1)

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here