for BCR patien ts who had no prior therapy), the sample size was determined clinically rather than statistically. Fifteen patients were enrolled in that cohort to provide preliminary efficacy, safety, PK and biomarker data for the regimen. 5.ANALYSIS SETS 5.1.Safety Analysis Set The safety analysis set includes all enrolled patients who receive at least one dose of one of the components of the regimen. 5.2.Full Analysis Set The full analysis set includes all enrolled patients. 5.3.Per-Protocol Analysis Set The per protocol (PP) analysis set includes all enrolled patients (for each indication) who receive at least one dose of the assigned regimen components administered on Cycle 1 Day 1 of study medication and who do not have major protocol deviations during the 28 days after the first vaccination . Major protocol deviations will be determined before data base release. 5.4.Modified Intent -to-Treat Analysis Set The modified Intention- to-Treat (mITT) is defined as all enrolled patients who received at least one dose of all assigned regimen components administered on Cycle 1 Day 1 of treatment. 5.5. P harmacodynamics A nalysis Set The pharmacod ynamics anal ysis set will be based on the mITT population. Apatient must have at least 1 valid and determinate assay result related to the proposed analy sis.