Evaluating Brentuximab Vedotin for Adults with Hodgkin's Lymphoma
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
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 |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 13 sites (Wroclaw, Dolnoslskie and 12 other locations) |
| Trial ID | NCT05100056 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients currently participating in other interventional clinical trials may not benefit from this study.
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 performed: Previous studies have shown promising results with Brentuximab Vedotin in treating Hodgkin's Lymphoma, indicating that this approach is supported by existing evidence.
Eligibility criteria
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 this trial is running
Wroclaw, Dolnoslskie and 12 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.