Status Assessment of Participants enrolled in TOWER study
Research type
Research Study
Full title
Long-term Follow-up of Adult Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia Relapsed Refractory Patients Enrolled in Study 00103311
IRAS ID
264043
Contact name
David Taussig
Contact email
Clinicaltrials.gov Identifier
2019-001575-37, European Clinical Trials Database (EudraCT) number; EUPAS27382, EU PAS register
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
This study (20180138) is to conduct a one time survival status assessment on patients that were alive at the last follow up and still participating in the Phase III Study 00103311(Tower) when the study ended earlier than planned. At the last follow up, there were 108 patients alive and still participating. This study is being also done to learn about potential change of treatment to blinatumomab of those patients who were still participating and alive at their last follow-up on the TOWER study. The current vital status (alive or deceased) of those patients will be used to update the overall survival estimates for blinatumomab from the TOWER study. This information has been requested as part of the process required for continuous approval of the drug in European Union (EU).
REC name
Wales REC 6
REC reference
20/WA/0054
Date of REC Opinion
5 Feb 2020
REC opinion
Favourable Opinion