Non-interventional, post-authorization efficacy study to assess the consistency of Breyanzi product quality and clinical outcomes in patients treated for relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma Grade 3B after 2 or more lines of systemic therapy in the post-marketing setting (CA082-1105)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/103853
• EU PAS number:
  EUPAS103852
• Study ID:
  103853
• Official title and acronym:
  Non-interventional, post-authorization efficacy study to assess the consistency of Breyanzi product quality and clinical outcomes in patients treated for relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma Grade 3B after 2 or more lines of systemic therapy in the post-marketing setting (CA082-1105)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Croatia

  Czechia

  Denmark

  Finland

  France

  Germany

  Greece

  Italy

  Netherlands

  Norway

  Poland

  Portugal

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  The aim of this study is to further assess the consistency of Breyanzi product quality measured at the time of release and clinical outcomes in patients treated in the post-marketing setting for relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma Grade 3B after 2 or more lines of systemic therapy. These data will contribute to the evaluation of the need for a revision of the finished product specifications.
• Study status:
  Planned

Research institutions and networks

Institutions

Bristol-Myers Squibb (BMS)

Networks

EBMT

Study timelines

Date when funding contract was signed

Planned: 18/08/2022

Study start date

Planned: 18/03/2023

Data analysis start date

Planned: 18/03/2023

Date of interim report, if expected

Planned: 31/12/2024

Date of final study report

Planned: 31/12/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb

Study protocol

Initial protocol

ca0821105-nir-protamend-v2-redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)
• Regulatory procedure number:
  EMEA/H/C/PSP/S/0098.1