NCT05886478

A Study in Adults With Cutaneous T-cell Lymphoma (CTCL) Retreated With Brentuximab Vedotin

Real-World Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to describe how effective and safe the re-treatment of adults with cutaneous T-cell lymphoma (CTCL) with brentuximab vedotin is. Another aim is to describe treatment patterns of persons with CTCL who have received brentuximab vedotin again. No treatment will be provided during this study. Information already existing in the participants' medical charts will be reviewed and collected.

Detailed description

This is a non-interventional, retrospective study of participants from France, Germany, Spain and Italy with CTCL who were retreated with brentuximab vedotin (BV) after a relapse in at least two different lines of therapy. The participants will be identified from their medical charts and those who meet the eligibility criteria will be included. The study will enroll approximately 50 participants. This multi-center trial will be conducted in Europe. The participants are assessed after the last dose of BV for approximately 4 months and followed up for at least 12 months after the re-treatment.

Conditions

• T-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	No intervention	As this is an observational study, no intervention will be administered.

Timeline

• Start date: 2024-02-08
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2023-06-02
• Last updated: 2024-12-04

Locations

11 sites across 4 countries: France, Germany, Italy, Spain