Post-authorisation safety study of allogeneic haematopoietic cell transplantation in patients treated with mogamulizumab

Study identification

• EU PAS number:
  EUPAS31436
• Study ID:
  31437
• Official title and acronym:
  Post-authorisation safety study of allogeneic haematopoietic cell transplantation in patients treated with mogamulizumab
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Planned

Research institutions and networks

Institutions

Center for International Blood and Marrow Transplant Research (CIBMTR)

Networks

Center for International Blood and Marrow Transplant Research (CIBMTR)

Study timelines

Date when funding contract was signed

Actual:12/08/2019

Study start date

Planned:01/01/2019

Date of final study report

Planned:31/07/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Kyowa Kirin Services

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)