Study identification

EU PAS number

EUPAS1000000118

Study ID

1000000118

Official title and acronym

INOtuzumab Treatment Retrospective Analysis for Navigating tranSITion to CD19 CAR-T. Real-world (RWD) treatment patterns and clinical outcomes in patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukaemia (ALL) treated with inotuzumab-ozogamicin (InO) as bridge to chimeric antigen receptor T-cell (CAR-T) therapy in Spain, the United Kingdom (UK) and the United States (US) (INO-TRANSIT)

DARWIN EU® study

No

Study countries

Spain
United Kingdom
United States

Study description

The study will be an international site-led (approximately 13 sites) retrospective observational chart review, assessing the characteristics and clinical outcomes of R/R ALL patients who received InO as a bridging therapy to CAR-T. Sites will be based in the US, UK, and Spain. This non-interventional study is designated as a Post-Authorization Safety Study (PASS) and is conducted voluntarily by Pfizer.

Study status

Ongoing
Research institutions and networks

Institutions

Adelphi Real World
United Kingdom
First published:
06/03/2024
InstitutionNon-Pharmaceutical companyENCePP partner
Pfizer
First published:
01/02/2024
Institution

Contact details

Alexander Russell-Smith

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable