Study identification

PURI

https://redirect.ema.europa.eu/resource/43069

EU PAS number

EUPAS23056

Study ID

43069

Official title and acronym

A Non-Interventional Post-Authorisation Safety Study (PASS) of Inotuzumab Ozogamicin to Characterize Complications Post-Hematopoietic Stem Cell Transplantation (HSCT) Following Inotuzumab Ozogamicin Treatment in Adult and Pediatric Patients with B-Cell Precursor Acute Lymphoblastic Leukemia (ALL).

DARWIN EU® study

No

Study countries

United States

Study description

This non-interventional post-authorization safety study (PASS) will use de-identified healthcare data from the CIBMTR database. The study will evaluate safety outcomes post-HSCT in patients who have relapsed or refractory B-cell precursor ALL who have been treated with inotuzumab ozogamicin prior to proceeding to HSCT. The study will utilize all relevant data available in the Center for International Blood and Marrow Transplantation Research (CIBMTR) database from US transplant centers for a 5 year period following the approval of inotuzumab ozogamicin in the US (i.e. 18 August 2017 -17 August 2022).

Study status

Finalised
Research institutions and networks

Institutions

Contact details

KOFI ASOMANING

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:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc
Study protocol
Initial protocol

INO PASS NI Study Protocol_FINAL

English (452.64 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 2 (specific obligation of marketing authorisation)