Brentuximab-5014: Brentuximab Vedotin Administration Registry and Outcomes Study in Polish CTCL Patients (BV-BALTIC study)

Study identification

• EU PAS number:
  EUPAS36934
• Study ID:
  44155
• Official title and acronym:
  Brentuximab-5014: Brentuximab Vedotin Administration Registry and Outcomes Study in Polish CTCL Patients (BV-BALTIC study)
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study description:
  This is a prospective, multicenter, observational, open-label study. This study is designed to document the management and clinical outcome of brentuximab vedotin in cutaneous T-cell lymphomas (CTCL) Polish patients who are eligible for Drug Program (DP) based on local real-world data in Poland. DP is a reimbursement program authorized by Ministry of Health in this country to grant patients access to highly specialized therapies, example biologics, such as brentuximab vedotin. The study is based on data collection from all patients enrolled for treatment in DP between October 2020 and October 2022. All patients will be enrolled in one Cohort, where patient will receive brentuximab vedotin as per summary of product characteristic (SmPC) and DP. Data collection will be scheduled in line with DP visits at every 6 weeks Visit 1 (Week 0) to Visit 9 (Week 48) for up to 16 cycles. The follow up of 6 months post treatment cessation, will be conducted on patients who completed all 16 cycles of treatment and achieved response/remission. The study is planned to be conducted in Poland. The overall duration of this study is approximately 42 months.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Takeda

Szymon Drygala

Study timelines

Date when funding contract was signed

Planned: 09/04/2020

Actual: 09/04/2020

Study start date

Planned: 20/10/2020

Actual: 17/11/2020

Data analysis start date

Planned: 01/08/2024

Date of final study report

Planned: 01/12/2024

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