NCT04837222

A Study of Brentuximab Vedotin in Adults With CD30-positive Lymphoma

Observational, Non-interventional, Multicenter Study Aimed at Collecting Prospective Data Related to Study Safety and Effectiveness in Real Clinical Practice in Patients With CD30+ Lymphoma (BRAVE Study)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Participants with CD30-positive lympoma will be treated with brentuximab vedotin according to their clinic's standard practice. The main aim of this study is to collect information on any side effects from treatment with brentuximab vedotin. Other aims are to collect information on how brentuximab vedotin is used to treat these participants and the outcomes of these participants.

Detailed description

This is an observational, non-interventional, prospective study in participants with CD30-positive lymphoma who are receiving or will receive the standard treatment of brentuximab vedotin. This study will assess the safety profile and effectiveness of brentuximab vedotin in the real-world clinical practice. The study will enroll approximately 1000 participants. The data will be collected and recorded in the medical record for the purpose of medical care and also recorded in electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort: • All participants with CD30-positive lymphoma This multi-center trial will be conducted in China. All participants will be followed up for 24 months unless withdrawal of Informed Consent, lost or death, whichever comes first. The overall duration of the study will be approximately 4 years.

Conditions

• Lymphoma

Interventions

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

Timeline

• Start date: 2021-06-07
• Primary completion: 2026-06-19
• Completion: 2026-06-19
• First posted: 2021-04-08
• Last updated: 2025-12-24

Locations

32 sites across 1 country: China

Regulatory

• FDA-regulated drug study