6 . 4 Study Parameters - Registered Patients who do not 
Receive the RMGT 
Some patients may be registered for the study and 
undergo autologous bone marrow transplant but will 
not have the retroviral gene transfer, either due 
to withdrawal of consent or because of a laboratory 
problem in processing the marked marrow. We will 
collect the data described in 6.212 and 6.213 above 
and will obtain PCR for the neo R gene on day 21 to 
document that no vector was infused. Such patients 
will be followed for survival and relapse until 
death. 
6 . 5 Interim Evaluation 
A critical question being addressed in this 
protocol is whether marrow purging is needed in 
autologous transplantation. The study will be 
evalutated after 4 relapsed patients within each 
disease catagory have been evaluated to determine 
if marrow purging should be added to the transplant 
regimen. We assume that marrow purging should be 
added if greater than 40% of the patients are shown 
to contain the marker gene (i.e. require purging) . 
To detect this level of marking with a 5% error 
will require 4 evaluable patients with marker 
observed in each of these patients. However, if at 
least one pateints does not show evidence of 
marking, the additional patients will be treated 
unpurged. 
7.0 DRUG FORMULATION AND PROCUREMENT 
7.1) Supplier 
The agent will be supplied by Genetic Therapy Inc. 
We will be applying for an IND. The agent will be 
shipped by Federal Express after the individual 
patient is entered onto the study. 
7.2) Storage 
The agent will be stored in a -70° freezer in the 
Bone Marrow Transplant Laboratories. 
7.3) Preparation 
A sample certificate of analysis for the LNL-6 
vector is contained in Table 3. The LNL6-marked 
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