Patient Evaluation: 
(Twenty lines not to exceed 75 characters per line! 
Pre- 
Treat . 
Every 
2-3 davs 
When WBC count > 1.5 K/ul 
everv 3 months in remission 
History, phys. exam 
X 
CBC , differential 
and platelet counts 
X 
X 
X 
SMA12 /PT/PTT/FIB/FSP 
and electrolytes* 
X 
X 
X 
PBlood Sample for PCR 
X 
X 
BM aspirate & BX** 
X 
X 
BM cytogenetics & PCR 
EKG/CXR/ urinalysis* 
Pulmonary function 
test 
X 
X 
X 
X 
* In addition as indicated by clinical and hematologic situations 
** Bone marrow aspirate +21 and +32 days post peripheral blood and marrow 
reinfusion as indicated and every three to four weeks for the first six 
months and then at six monthly intervals for four additional years after 
hematopoietic recovery and for morphology cytogenetics, and PCR for bcr- 
abl and neo and at the time of relapse if that should occur. 
Miscellaneous Information: (Include any other information that you feel is pertinent to the study) 
(Three lines not to exceed 75 characters per line) 
Statistical Considerations: 
We plan to initially study 10 patients. . All 10 patients will be available for 
analysis of retroviral marking on the basis of the fact that a high 
probability exists that between 200 to 20,000 retrovirally marked CLL cells 
will be infused with each marrow. It is probable that several of the 10 
patients will produce marked cells at relapse if the marrow is the origin of 
the relapse. The marking virus has been approved for use in man (see Appendix 
B) . The percent of colonies positive for the vector used to mark the marrow 
will be measured during and after hematopoietic recovery at four weekly 
intervals for the first 12 months. 
Objectives: 
(Twelve lines not to exceed 75 cheracters per line) 
To evaluate independently two different purging steps in the 
autologous marrow of CLL patients, the origin of relapse in CLL 
patients following intensive preparative therapy, transplantation 
with autologous cells marked with safety modified retroviruses, 
and the, relative level of contamination of each cell source 
(peripheral blood or marrow) with leukemia cells following 
purging. The marrow will be purged with CD34 positive selection 
and subjected to CD19 negative selection. 
[388] 
Recombinant DNA Research, Volume 16 
