From June 2000 to October 2007, 501 consecutive patients (1 to 18 years old) with newly diagnosed ALL were enrolled in Total XV Study at St. Jude Children’s Research Hospital (n=411) or at Cook Children’s Medical Center (n=90). Three patients were subsequently excluded because of a revised diagnosis of myeloid leukemia. The protocol was approved by the institutional review boards and registered at ClinicalTrials.gov, number NCT00137111. Signed informed consent was obtained from the parents or guardians, with assent from the patients, as appropriate.
The diagnostic criteria of ALL was described previously.14 (link) CNS status was defined as CNS-1, CNS-2, CNS-3, or traumatic lumbar puncture with blasts.12 (link) MRD was determined by flow cytometry and/or polymerase-chain-reaction.15 (link),16 (link)