Evaluation of Long-term Safety in Paediatric Patients With B-precursor Acute Lymphoblastic Leukemia (ALL) who Have Been Treated With Either Blinatumomab or Chemotherapy, Followed by Transplantation (20180130) (Paediatric long-term follow up study)

Study identification

• EU PAS number:
  EUPAS33862
• Study ID:
  41742
• Official title and acronym:
  Evaluation of Long-term Safety in Paediatric Patients With B-precursor Acute Lymphoblastic Leukemia (ALL) who Have Been Treated With Either Blinatumomab or Chemotherapy, Followed by Transplantation (20180130) (Paediatric long-term follow up study)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Brazil

  Bulgaria

  Canada

  Colombia

  Czechia

  Finland

  Greece

  Israel

  Italy

  Mexico

  Poland

  Spain

  Taiwan

  Türkiye

  United States
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 30/05/2020

Study start date

Planned: 30/06/2021

Actual: 24/06/2021

Data analysis start date

Planned: 24/06/2038

Date of final study report

Planned: 09/12/2038

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)