every three weeks for the first six months and then 
at six monthly intervals after that. Studies at 
remission will include CBC, platelet count, 
differential and SMA 12 and marrow for cytogenetics, 
morphology, and PCR every thfee to four weeks for the 
first six months and every six months for four years 
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 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 to four 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 
successfully marked, or in whom failure to engraft 
with the marked marrow, will be removed from the 
study . 
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Recombinant DNA Research, Volume 16 
