A database analysis in Patients with Acute Lymphoblastic Leukemia
Research type
Research Study
Full title
An Analysis of Historical Data on Hematological Remission and Survival Among Adult Patients with Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia.
IRAS ID
134135
Contact name
Adele Fielding
Contact email
Sponsor organisation
Amgen Ltd
Research summary
This analysis aims to address the limitations in studying Acute Lymphoblastic Leukaemia, which has very few patients available to recruit into comparative studies. The proposed analyses will use anonymised data which have already been collected (and in many cases already published as individual trails) from large national trials and databases throughout Europe and the US. The patients whose data are being used within the UK were all enrolled in the multicentre UKALL 12 trial and have already consented to have their data stored and used for future research projects. The raw data to be supplied for the proposed analysis have already been analysed and published by the trial investigators.
Patient data will be included where it involved patients that have been treated for their disease but have relapsed or not responded to their initial treatment. The analyses done in this study will look at the rates of complete remission, overall survival, and rates of allogeneic haematopoietic stem cell transplantation. The aim is to the use the results from this study to understand the impact a new treatment, that is still under investigation, has on patient who have similar characteristics.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
13/NE/0215
Date of REC Opinion
13 Jul 2013
REC opinion
Favourable Opinion