MEDICAL RECORD 
STUDY NUMBER: 
CONTINUATION SHEET for either: 
m!u M° nse 2 t P f rtici P ate ,n A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
CONTINUATION: page 6 nf 14 
pain, low blood pressure and rash. It is also possible that 
this drug may increase the chance of worsening of your- 
leukemia, however we think this is very unlikely. Although 
these side effects are possible they are not likely to occur 
at the doses you will be receiving in this study. Most 
symptoms will disappear immediately after discontinuation of 
the drug. 
4) Peripheral Blood Stem Cell (PBSC) Harvest will begin at 
least 30 days after the daunorubicin/cytarabine chemotherapy 
treatment and within two weeks of a diagnostic marrow report 
showing >30% cellularity and .<10% blast cells. "Stem cells" 
collected from the peripheral (circulating) blood may lead 
to quicker recovery after transplantation than bone marrow 
and may be less contaminated by leukemia cells than bone 
marrow. It is not certain, however, if the effect achieved 
is as long lasting as it is with bone marrow transplants, 
thus we are using both types of cells together to try to 
obtain the benefits of each. 
For the actual harvest of the stem cells you will be hooked 
up by your central catheter line to an apheresis machine for 
several hours every day or every other day for a total of" 5- 
10 pheresis sessions. Your blood will be separated as it 
slowly flows through the machine. The machine will collect 
your peripheral stem cells and return the rest of your blood 
through your catheter. These peripheral blood cells will 
then be frozen for storage until you undergo 
transplantation. Small numbers of these cells will be taken 
before freezing and used for a number of laboratory tests to 
find out if there are leukemic cells present, if there are 
enough "stem cells" to support you through a transplant 
procedure, and to help us understand more about CML and 
whether genetic therapies could be used to treat CML in the 
future. 
If your leukemia has progressed or failed to respond 
adequately as determined by your doctor, proceeding with the 
stem cell harvest and transplant should not be done since 
your chances of benefiting from the treatment would be 
extremely low. 
'ATIENT 
IDENTIFICATION 
CONTINUATION SHEET for either: 
pages. 
Recombinant DNA Research, Volume 16 
[185] 
