Study Cohort:
As per the above-mentioned eligibility criteria the study cohort
comprised of children newly diagnosed with ALL during the period January
2002 until December 2018 aged 1 to 14 years, either refractory to
first-line treatment or experiencing relapse at medullary and / or
extra-medullary site. The study cohort included patients who received
treatment for relapse during the study defined period i.e. January 2002
to December 2018 at King Faisal Specialist Hospital & Research Centre
(KFSH&RC), Jeddah, Saudi Arabia.
The study commenced after obtained regulatory approvals from the
Institutional Review Board (IRB) utilizing the IRB-approved study Case
Report Form (CRF) to abstract data from paper-based and electronic
medical charts of the identified study cohort. Date was collected and
managed utilizing the REDCap electronic data capture softed hosted by
KFSH&RC, Jeddah. The overall conduct of the study was in compliance in
Good Clinical Practice (GCP) guidelines and no personal identifiable
information ever collected throughout the conduct of the study, while
access to study data restricted to the research team through
password-controlled users.