Recombinant DNA Advisory Committee - 09/14-15/92 
Introduction of the neo R gene into the ABM cells will allow the investigators to identify 
the source of relapse, therefore, providing an opportunity to improve the systemic and/or 
in vitro purging techniques. Additional data may be obtained regarding the clonality of 
relapse, efficiency of normal versus neoplastic cell separation procedures, and efficiency 
of systemic preparatory therapy. 
Both the LNL6 and GINa vectors have been reviewed and approved for use by the RAC 
in previously submitted protocols. The difference between this protocol and previous 
studies is the use of bone marrow and peripheral blood stem cells. PCR analysis will be 
performed to confirm stem cell transduction with the neo R gene. Neo R colonies will be 
positively selected in G418 medium. The investigators will perform assays that readily 
distinguish the two vectors. 
CLL patients will be eligible to participate in this study based on the ability to transduce 
and grow their ABM cells. Although data was not provided regarding the frequency of 
transduction in CLL cells in the original submission, Dr. Deisseroth has indicated that 
this data now exists. 
Dr. Doi said that he inquired about the retention of the LNL6 and the GINa genomes, 
and that Dr. Deisseroth had responded to his question satisfactorily. Dr. Doi said that 
Dr. Deisseroth also responded to the concern that if the conventional dose of 
chemotherapy does not reduce the percentage of abnormal cells below 0.01%, what is 
the probability of improving the in vitro purging methods. 
Dr. Doi stated that the protocol is designed to answer questions other than those 
addressed by the previously approved acute myelogenous leukemia (AML) and chronic 
myelogenous leukemia (CML) protocols, and the study is experimentally sound. 
Therefore, the protocol should be approved. 
Review-Dr. Bourquin 
In Dr. Bourquin's absence, Dr. Doi summarized Dr. Bourquin's review. Since the LNL6 
and GINa vectors were previously approved, there is no objection to their use. Although 
this protocol does not provide an immediate benefit to patients participating in this 
study, the information obtained from this protocol will provide a great potential for 
benefit to patients in the future. The consent form is well presented, and the patients 
will be adequately informed of the potential risks. In addition, the patient information, 
manuals and video presentation provides comprehensive explanation of the study. 
Review-Ms. Meyers 
Ms. Meyers was also unable to attend the meeting. Dr. Doi summarized Ms. Meyer's 
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