Real-world Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients (Brentuximab-5020)

Study identification

• EU PAS number:
  EUPAS104804
• Study ID:
  104805
• Official title and acronym:
  Real-world Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients (Brentuximab-5020)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain
• Study description:
  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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Planned:01/12/2021

Study start date

Planned:31/07/2024

Actual:10/01/2024

Date of final study report

Planned:30/09/2024

Actual:14/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable