An observational study describing the effectiveness and safety of BLINCYTO® in Chinese adults with Philadelphia chromosome-positive relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (Ph+ R/R B-cell precursor ALL) (20210061)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107859
• EU PAS number:
  EUPAS107858
• Study ID:
  107859
• Official title and acronym:
  An observational study describing the effectiveness and safety of BLINCYTO® in Chinese adults with Philadelphia chromosome-positive relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (Ph+ R/R B-cell precursor ALL) (20210061)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Actual: 12/12/2022

Study start date

Planned: 06/02/2024

Actual: 20/02/2024

Data analysis start date

Planned: 24/10/2024

Actual: 24/10/2024

Date of interim report, if expected

Planned: 01/11/2024

Date of final study report

Planned: 18/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol-Published Original blinatumomab 20210061 .pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable