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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104805
• 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

  Italy

  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:
  Ongoing

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 interim report, if expected

Planned: 30/07/2024

Date of final study report

Planned: 30/09/2024

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