NCT05100056

A Study of Brentuximab Vedotin in 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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
OTHER	No Intervention	This is a non-interventional study.

Timeline

• Start date: 2022-03-08
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2021-10-29
• Last updated: 2025-09-09

Locations

13 sites across 1 country: Poland