Dating protocal for adults
These results were then used to adjust the dose given 2 weeks after obtaining the sample.Samples had to be obtained 7 days after the prior dose to be considered evaluable.A priori, it was determined that the treatment would be considered ‘feasible’ if the one-sided lower bound of the 90% exact binomial confidence interval (CI) for feasibility (that is, the proportion of patients in whom it was feasible to administer this regimen for 30 weeks) was 60% or higher, taking into account patients who were removed from the study to undergo allogeneic stem cell transplantation.Outcome events were death during induction therapy, failure to achieve CR at the end of the 4-week induction phase, death during remission and relapse.Patients with persistent leukemia at the end of the first month of treatment were removed from the protocol and given alternative therapy at the discretion of the treating physician.
The dexamethasone dose was reduced when starting the continuation phase.
Molecular analysis with real-time PCR allowed for the detection of BCR-ABL.
The primary end point of this study was the proportion of patients who completed 30 weeks of asparaginase treatment.
The protocol was amended in September 2006 to add imatinib at a dose of 600 mg daily to all patients who were Philadelphia chromosome positive.
Dexamethasone was permanently discontinued in the setting of symptomatic, radiographically confirmed osteonecrosis.