enhanced cytotoxic effector function in animal models. Again such constructs 
would need to include the Tk suicide gene. 
11.0 OFF-STUDY CRITERIA 
11.1 Any patient who develops irreversible life-threatening non-hematologic organ 
system dysfunction (toxicity grade 3 or 4) considered to be primarily related to 
CTL injection will be removed from this protocol and will not be eligible for 
subsequent treatment with CTLs. 
11.2 Any questions regarding patients on this study should be addressed to Dr. 
Heslop (Ext 2529) or Dr. Brenner (Ext 410). 
12.0 RECORDS TO BE KEPT 
Flow sheets documenting dates and doses of therapy as well as clinical chemistries, 
hematologic parameters, the clinical status and occurrence of any adverse events and 
subsequent interventions are to be kept on all patients. 
Imaging reports 
Surgical summaries 
Autopsy summaries, where appropriate 
Date of entry on to other appended protocols 
Informed consent documents 
All required clinical evaluation records will be the responsibility of Dr. Helen Heslop 
who will also be responsible for analysis of the clinical outcome and toxicity. 
The laboratory evaluation of immunological efficacy and gene insertion will be the 
responsibility of Drs. Heslop and Brenner. The laboratory evaluation of EBV DNA 
persistence will be the responsibility of Dr Rooney. 
13.0 REPORTING REQUIREMENTS 
13.1 Register all patients with Bone Marrow Transplant Data Manager at Ext 410. 
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