procedure does not pose an unacceptable 
risk to the patients or public. One 
theoretical side effect that is put 
forward in the consent is that the RMGT 
might cause a second malignancy. 
Secondary malignancies could take months 
or longer to develop, therefore, 
screening for adverse reactions will be a 
long-term process. 
5.7) Conditions for Off-Studv 
1. Patients will be considered on study until 
death unless they meet the criteria listed 
below. Patients who relapse will have 
leukemic cells analyzed for vector presence at 
6 month intervals and at the time of any 
subsequent relapses. These tests are 
necessary to determine if vector persists and 
also to study the number of leukemic clones 
that contain LNL-6 (Southern Blot) . 
2 . Patients may withdraw their consent to 
participate right up to the time of 
transplantation. If the gene transfer does 
not take place in registered patients, 
patients will be considered off study after 
the day 21 testing (see Section 6.3). Such 
patients will be followed for survival and 
relapse until death. 
3. If the LNL-6 treated cells are not suitable 
for infusion, the patient will be taken off 
study after the day 21 testing (see Section 
6.3). The patient will be followed for 
survival and relapse until death. 
6.0 STUDY PARAMETERS 
6 . 1) Pretreatment Evaluation 
The following tests will be performed and reviewed 
by the designated transplant physician before the 
preparative transplant regimen is initiated: 
6.11) Comprehensive medical history and 
physical examination (Pertinent medical 
records and slides from the referring 
physician and/or institution must be 
available at the time of this evaluation) 
Recombinant DNA Research, Volume 15 
[481] 
