8 . STATISTICAL CONSIDERATIONS 
8 . 1 Definitions 
8.1.1 Evaluable for Analysis 
All patients who receive at least one lymphocyte infusion will be analyzed 
for safety (with respect to AEs) and where possible immunological activity. 
Patients who discontinue study prematurely will not be replaced but all due 
effort will be made to follow them for outcome variables. These patients 
will be censored from the analysis at the point at which their data are no 
longer available. 
8.1.2 Dose-Limiting Toxicity (DLT) 
Any of the following adverse events which are considered probably or 
definitely related to genetically modified lymphocyte transfusions: 
• Grade 3 or greater adverse event (see Appendix D); 
• Unacceptable grade 2 adverse event in the opinion of the Principal 
Investigator; 
• Other severe or life-threatening complication or abnormality. 
8.1.3 MaximumT olerable Dose (MTD) 
The maximum dose tested at which 33% or fewer patients experience DLT. 
8.1.4 Criterion for Dose Advancement 
All patients within a dose cohort must complete a single infusion of 
lymphocytes and be evaluable for immediate dose-limiting toxicity. Either 
less than 2 of 6 patients or less than 4 of 9 patients may experience a dose- 
limiting toxicity in order to advance to the next dose level. 
Specific criteria for advancement to the next higher dose level are as 
follows: 
DLT in: 
Then: DLT in: 
Then: 
0 or 1 of 6 Pts -> 
Start next 
dose level 
2 of 6 Pts -> 
Add 3 Pts -> 0 or 1 of 3 -> 
Start next dose level 
> 3 of 6 Pts -> 
> 2 of 3 -> 
Stop enrollment 
at this dose; 
do not start 
next dose level 
Stop enrollment at this 
dose; previous level 
is MTD 
All patients who had been randomized into cohorts 1 , 2, and 3 for Period I 
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