F 
MEDICAL RECORD 
CONTINUATION SHEET for either: 
miw oil lo M° nSe D !° P f rti f'P ate ln A Clinical Research Study 
NIH 2514-2, Minor Patients Assent to Participate In A Clinical Research Study - 
STUDY NUMBER: 
_ CONTINUATION: page 3_ of pages' 
Pre-study testing: 
Prior to entering this study you will undergo many tests to 
determine the status of your leukemia as well as the status of your 
other body functions. A complete history and physical exam will be 
done. Blood (about 8 Tablespoons) will be drawn for laboratory 
tests to determine the state of your bone marrow, kidneys and 
liver. Additionally, you will be tested for possible exposure to 
or infection with viruses such as CMV, Herpes, Hepatitis, and HIV. 
Heart and lung function tests will be performed to make sure that 
these organs are capable of undergoing high-dose therapy and 
transplant. The number of leukemic and normal cells in your bone 
marrow will be tested with a bone marrow aspirate and biopsy, and 
the chromosomes analysed. A portion of the bone marrow samples 
will be saved for research purposes. 
Central Line Placement 
When convenient to your specific treatment schedule, you will 
have a double or triple lumen (opening) tube placed in a large vein 
in your neck or upper chest. This will be done under local orf 
general anesthesia in the operating room. This special intravenous 
line makes possible frequent blood drawing, your chemotherapy 
treatments, your peripheral blood stem cell harvest, and your 
transplant procedure. 
i >• 
Placement of the central venous catheter may cause pain where 
the catheter is inserted, bleeding, bruising, and infection. 
Rarely the lung can be punctured during the insertion process. 
Group 1 Patients only fist chronic phase 1 : 
1). INTERFERON TREATMENT : You will be treated with recombinant 
Interferon alpha injections subcutaneously (under the skin) 3- 
7 days a week in an effort to lower your high white blood cell 
count and to control other symptoms of the chronic phase of 
your leukemia. We also hope that this treatment will reduce 
the number of Philadelphia chromosome positive cells in your 
bone marrow and blood. Patients who achieve -a complete 
response (0-5% Ph+ cells) will continue Interferon 
indefinitely at the discretion of their referring physician. 
Recent research studies have suggested that patients showing 
a decrease in the number of Philadelphia chromosome positive 
PATIENT IDENTIFICATION 
[182] 
CONTINUATION SHEET for either: 
Recombinant DNA Research, Volume 16 
CPO >1 t -S29 
