Study identification

PURI

https://redirect.ema.europa.eu/resource/42020

EU PAS number

EUPAS32497

Study ID

42020

Official title and acronym

Registry study to assess the long-term safety of patients with B lymphocyte malignancies treated with tisagenlecleucel

DARWIN EU® study

No

Study countries

Austria
Belgium
Canada
Croatia
Czechia
Denmark
Finland
France
Germany
Greece
Israel
Italy
Korea, Republic of
Netherlands
Norway
Poland
Spain
Switzerland
Taiwan
United Kingdom
United States

Study description

This post-authorization safety study (PASS) is a global, non-interventional, multi-database study that obtains data on patients treated with marketed tisagenlecleucel in an authorized indication. Patient data is retrieved from established Registries conducted by the following groups: • The European Society for Blood and Marrow Transplantation (EBMT) and • The Center for International Blood and Marrow Transplant Research (CIBMTR) - US

Study status

Ongoing
Research institution and networks

Institutions

Networks

European Society for Blood and Marrow Transplantation (EBMT), Center for International Blood and Marrow Transplant Research (CIBMTR)

Contact details

Novartis Clinical Disclosure Officer

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG
Study protocol
Initial protocol

ctl019b2401-v02--protocol amendment_Redacted

English (396.27 KB - PDF)View document
Updated protocol

cctl019b2401-v07-protocol amendment_Redacted

English (3.15 MB - 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)