Long-term Follow-up of Adult Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia Relapsed Refractory Patients Enrolled in Study 00103311 (TOWER Follow-up Study)

Study identification

• EU PAS number:
  EUPAS27382
• Study ID:
  39068
• Official title and acronym:
  Long-term Follow-up of Adult Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia Relapsed Refractory Patients Enrolled in Study 00103311 (TOWER Follow-up Study)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Belgium

  Bulgaria

  Canada

  France

  Germany

  Greece

  Ireland

  Israel

  Italy

  Korea, Republic of

  Mexico

  Poland

  Russian Federation

  Spain

  Taiwan

  Türkiye

  United Kingdom

  United States
• Study description:
  No information provided.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 65 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:31/01/2019

Actual:31/01/2019

Study start date

Planned:06/12/2019

Actual:02/12/2019

Data analysis start date

Planned:25/09/2020

Actual:07/09/2020

Date of final study report

Planned:30/12/2020

Actual:07/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)