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)

Study summary

No information provided.

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

Pfizer

Study timelines

Date when funding contract was signed

Planned:22/08/2023

Actual:22/08/2023

Study start date

Planned:01/07/2024

Actual:16/12/2024

Date of final study report

Planned:02/12/2025

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

Other study registration identification numbers and links

Pfizer study number B1931044