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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Study details
    Hodgkin Lymphoma

NCT05100056

Takeda

17 June 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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