Study identification

PURI

https://redirect.ema.europa.eu/resource/103856

EU PAS number

EUPAS103855

Study ID

103856

Official title and acronym

Non-interventional, post-authorization safety study (PASS) of patients treated with commercially available liso-cel (lisocabtagene maraleucel) for large B-cell lymphomas (JCAR017-BCM-005)

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
United States

Study description

The purpose of this PASS is to further characterize the safety profile of liso-cel in the postmarketing setting. This study will include patients from existing independent registries, such as, but not limited to, the European Society for Blood and Marrow Transplantation (EBMT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The JCAR017-BCM-005 study will be part of the overall liso-cel Risk Management Plan (RMP) including any required regional Pharmacovigilance Plan (PVP) outside the European Union (EU).

Study status

Ongoing
Research institutions and networks

Institutions

CIBMTR United States

Networks

EBMT

Contact details

Montserrat Miret

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

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
Study protocol
Initial protocol

jcar017-bcm-005-pass-prot 30-aug-2022-redacted-v2

English (736.05 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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