Recombinant DNA Adviaory Committee - 09/14-15/92 
Dr. Krogstad agreed with the statements provided by Dr. Schaechter and added that 
there is no evidence that tetracycline is necessary for the treatment of the clinical entity. 
Review --Dr. Murray 
Dr. Murray concurred with the positive assessment of the proposed experiment offered 
by the other primary reviewers. 
Committee Motion 
A motion was made by Dr. Schaechter and seconded by Dr. Haselkom to approve the 
proposal. Dr. Murray called for a vote. The motion passed by a vote of 15 in favor, 0 
opposed, and 1 abstention. 
IX. ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING A HUMAN 
GENE TRANSFER PROTOCOL ENTITLED: USE OF RETROVIRAL MARKERS TO 
EVALUATE THE EFFICACY OF PURGING AND TO DISCRIMINATE BETWEEN 
RELAPSE WHICH ARISES FROM SYSTEMIC DISEASE REMAINING AFTER 
PREPARATIVE THERAPY VERSUS RELAPSE DUE TO RESIDUAL NEOPLASTIC 
CELLS IN AUTOLOGOUS MARROW FOLLOWING PURGING IN PATIENTS WITH 
CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)/ DR. DEISSEROTH 
Review— Dr. Doi 
Dr. Murray called on Dr. Doi to present his primary review of the protocol submitted by 
Dr. Albert Deisseroth of MD Anderson Cancer Center, University of Texas, Houston, 
Texas. Dr. Doi presented his review of this protocol. This protocol is similar to other 
leukemia and leukemia remission studies that have been reviewed and approved by the 
RAC and NIH. The investigators will use in vitro gene marking with either the LNL6 or 
GINa vectors to test the efficacy of purging methods and to determine whether relapse 
after autologous transplantation results from residual systemic disease or from neoplastic 
cells remaining in the ABM preparations used for the transplantation of CLL patients. 
ABM and peripheral blood stem cells will be harvested and stored after induction of 
remission. The ABM cells then will be reinfused into the patient to restore marrow 
function after intensive systemic and in vitro preparative therapy. The investigators will 
gain insights regarding the necessity of preparative therapy from this study. In some 
CLL patients, the remission period is greater than one year, suggesting that relapse from 
leukemic cells contaminating the ABM preparation infused after preparative therapy. 
Patients demonstrating a short remission period suggest that relapse may be due to 
residual systemic disease. 
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