A Non-Interventional Post-Authorisation Safety Study to Characterize Toxicity following Gemtuzumab Ozogamicin Treatment and Hematopoietic Stem Cell Transplantation in Adult Patients with Acute Myeloid Leukemia.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37476
• EU PAS number:
  EUPAS37475
• Study ID:
  37476
• Official title and acronym:
  A Non-Interventional Post-Authorisation Safety Study to Characterize Toxicity following Gemtuzumab Ozogamicin Treatment and Hematopoietic Stem Cell Transplantation in Adult Patients with Acute Myeloid Leukemia.
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This non-interventional study is being conducted to characterize toxicity after hematopoietic stem cell transplantation (HSCT) in adult patients who receive GO post-approval in the US
• Study status:
  Planned

Research institutions and networks

Institutions

Center for International Blood and Marrow Transplant Research (CIBMTR)

Study timelines

Date when funding contract was signed

Actual: 07/07/2020

Study start date

Planned: 02/09/2021

Date of final study report

Planned: 30/03/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

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

B1761034