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

Recruiting

• Conditions: Hodgkin Lymphoma
• Interventions: Other: No Intervention

• Registration Number: NCT05100056
• Lead Sponsor: Takeda

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-10-29
• Study Start: 2022-03-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HL Participants: BV Salvage Pre-ASCT	No Intervention	Participants diagnosed with HL who undergone or undergoing pre-ASCT BV salvage and continue with post-ASCT treatment will be observed prospectively over 24-month period after treatment cessation.
HL Participants: BV Consolidation Treatment Post-ASCT	No Intervention	Participants diagnosed with HL who undergone or undergoing post-ASCT BV consolidation treatment will be observed prospectively over 24-month period after treatment cessation.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) as Assessed by Investigator	From initiation of BV treatment post-ASCT until disease progression or relapse, or death (up to 36 months)	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From initiation of BV treatment until death from any cause (up to 36 months)	OS is defined as the time from initiation of therapy to death from any cause. It will be analyzed using Kaplan-Meier method.

Trial Locations

Locations (13)

Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli; 🇵🇱 Lublin, Lubelskie, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Krakowie; 🇵🇱 Krakow, Malopolskie, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu; 🇵🇱 Wroclaw, Dolnoslskie, Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie; 🇵🇱 Krakow, Malopolskie, Poland

Uniwersyteckie Centrum Kliniczne, Gdansk; 🇵🇱 Gdansk, Pomorskie, Poland

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu; 🇵🇱 Poznan, Wielkopolskie, Poland

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii, im. M. Kopernika w Lodzi; 🇵🇱 Lodz, Lodzkie, Poland

Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slskiego Uniwersytetu Medycznego w Katowicach; 🇵🇱 Katowice, Slskie, Poland

NU-MED Specjalistyczny Szpital Onkologiczny Tomaszow Mazowiecki; 🇵🇱 Tomaszow Mazowiecki, Mazowieckie, Poland

Instytut Hematologii i Transfuzjologii; 🇵🇱 Warszawa, Mazowieckie, Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w Olsztynie; 🇵🇱 Olsztyn, Warminsko-mazurskie, Poland

Uniwersyteckie Centrum Kliniczne WUM; 🇵🇱 Warszawa, Mazowieckie, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy; 🇵🇱 Warszawa, Mazowieckie, Poland