Study identification

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

Networks

EBMT

Contact details

Montserrat Miret

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb
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