3.29) Patients who have decreased liver 
function as demonstrated by a total 
bilirubin of greater than 2.5 mg/dL. 
3.210) Patients who have diabetes mellitus will 
be considered on a case-by-case basis. 
However, patients with diabetes who are 
not controlled by medical management will 
be ineligible. 
3.211) Psychiatric illness requiring psychiatric 
counseling or medical intervention other 
than antidepressant medications may make 
an individual ineligible. 
3.212) Psychosocial assessment by the bone 
marrow transplant team may identify 
individuals for whom this form of therapy 
may be contraindicated. These decisions 
will be based upon estimated adequacy of 
patient support systems and prediction of 
..Ml' 
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patient 1 s 
compliance 
with medications, 
JL 
required 
diagnostic 
procedures and/or 
follow up 
care. 
4 t/ ; | 
O' ! 
4 . 0 PATIENT ENTRY 
( T 
4.1} Registration at the 
time of marrow harvest: 
5b 
Buffet | 
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Patients must be registered at 
the time of bone 
marrow harvest so that the transduction can be 
done. However, patients will not be considered 
actively on study until the conditioning regimen 
for the bone marrow transplant has been started. 
Prior to registration the following must be 
confirmed: 
4.11) Harvest guidelines (Section 5.1) have 
been met 
4.12) Informed consent signed 
4.2) Registration at the time of bone marrow transplant : 
Patients must be registered at the time the bone 
marrow conditioning regimen is started. Prior to 
entry on-study the following must be confirmed: 
4.21) Eligibility criteria have been met 
(Section 3.0) 
[474] 
Recombinant DNA Research, Volume 15 
