INOtuzumab Treatment Retrospective Analysis for Navigating tranSITion to CD19 CAR-T (INO-TRANSIT)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000118
• EU PAS number:
  EUPAS1000000118
• Study ID:
  1000000118
• Official title and acronym:
  INOtuzumab Treatment Retrospective Analysis for Navigating tranSITion to CD19 CAR-T (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:
  Planned

Research institution and networks

Institutions

Adelphi Real World

United Kingdom

Pfizer

Study timelines

Date when funding contract was signed

Planned: 22/08/2023

Actual: 22/08/2023

Study start date

Planned: 01/07/2024

Date of final study report

Planned: 01/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

Study protocol

Initial protocol

B1931044 Non Interventional Study Protocol v1.0_11Apr24.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Pfizer study number B1931044