A Study of Brentuximab Vedotin in Adults With Hodgkin's Lymphoma

Hodgkin Lymphoma Clinical Trial

— BV-MAZOVIA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100056
• Other study ID #: Brentuximab-5018
• Status: Recruiting
• Start date: March 8, 2022
• Est. completion date: June 1, 2026

Study information

• Verified date: June 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Other:
• No Intervention
This is a non-interventional study.

Locations

Country	Name	City	State
Poland	Uniwersyteckie Centrum Kliniczne, Gdansk	Gdansk	Pomorskie
Poland	Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slskiego Uniwersytetu Medycznego w Katowicach	Katowice	Slskie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Krakowie	Krakow	Malopolskie
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie	Krakow	Malopolskie
Poland	Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii, im. M. Kopernika w Lodzi	Lodz	Lodzkie
Poland	Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli	Lublin	Lubelskie
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w Olsztynie	Olsztyn	Warminsko-mazurskie
Poland	Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu	Poznan	Wielkopolskie
Poland	NU-MED Specjalistyczny Szpital Onkologiczny Tomaszow Mazowiecki	Tomaszow Mazowiecki	Mazowieckie
Poland	Instytut Hematologii i Transfuzjologii	Warszawa	Mazowieckie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy	Warszawa	Mazowieckie
Poland	Uniwersyteckie Centrum Kliniczne WUM	Warszawa	Mazowieckie
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw	Dolnoslskie

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From initiation of BV treatment post-ASCT until disease progression or relapse, or death (up to 36 months)
Secondary	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.	From initiation of BV treatment until death from any cause (up to 36 months)

External Links

•   To obtain more information on the study, click here/on this link