II 
7.3 Bone marrow aspirate and biopsy for morphologic 
pathology, cytogenetics, FISH, and PCR for bcr-abl and 
neo should be performed at marrow recovery (when WBC 
count > 2.0 K/ul) . 
7.4 Upon marrow recovery, a full work-up including CBC, 
platelet count and differential, SMA 12, and marrow 
studies including cytogenetics will be performed. 
Studies at remission will include CBC, platelet count, 
differential and SMA 12 every 1-4 weeks, marrow studies 
with cytogenetics every 6 months and as indicated by 
disease status. 
7.5 The following will be collected before and after vector 
exposure and after hematopoietic recovery and on a six 
monthly basis for five years after transplant: 2 x 10 6 
cells for NEO PCR, 2 x 10 6 blood and marrow cells for 
viral PCR, 2 x 10 6 cells for NIH3T3 viral amplification 
studies, 1 x 10 7 cells for Southerns and 10 cc of a red 
top tube for Western blots for viral antibodies. 
The analysis of the bone marrow with cytogenetics, PCR 
for BCR-ABL and Neo along with an analysis of the sample 
for actin mRNA is summarized below in the following 
table. 
ANALYSIS OF THE PERIPHERAL BLOOD AND BONE MARROW FOR 
EVIDENCE OF VIRALLY MARKED 
CELLS IN NORMAL AND 
LEUKEMIC POPULATIONS 
I. Analysis of peripheral blood and bone marrow before 
exposure to virus. 
II. Analysis of peripheral blood and bone marrow after 
exposure to virus before culturing or freezing. 
III. Analysis of cells after thawing and before 
infusion. 
IV. Analysis every three weeks during and after 
hematopoietic recovery until six months and at 6 
monthly intervals for an additional 4 years or 
until the time of relapse. 
8.0 CRITERIA FOR RESPONSE AND TOXICITY 
8.1 Criteria for toxicity will be as follows: Failure of the 
peripheral blood or marrow to engraft failure to achieve 
and ANC of 500 by 80 days and the need to use back-up 
collections of hematopoietic peripheral blood or marrow 
stem cells for reconstitution. Toxicity criteria are 
summarized in Appendix H. 
9.0 CRITERIA FOR REMOVAL FROM STUDY 
9.1 Patients whose peripheral blood or bone marrow is not 
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