MEDICAL RECORD 
CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY 
• Adult Patient or • Parent, for Minor Patient 
INSTITI 1TF: National 
Heart, Lung and Blood Institute 
STUDY NUMBER PRINCIPAL INVESTIGATOR: Cynthia E. Dunbar, M.D. 
.9TI IDY TITl E* High-Dose Cyclophosphamide and Total Body Irradiation with Autologous Bone 
Marrow and Peripheral Blood Stem Cell Support followed by Interferon for Chronic 
Myelogenous leukemia. 
INTRODUCTION 
We invite you (or your child) to take part in a research study at the National Institutes of Health. It is important that you 
read and understand several general principles that apply to all who take part in our studies: (a) taking part in the study 
is entirely voluntary; (b) personal benefit may not result from taking part in the study, but knowledge may be gained that 
will benefit others; (c) you may withdraw from the study at any time without penalty or loss of any benefits to which you 
are otherwise entitled. The nature of the study, the risks, inconveniences, discomforts, and other pertinent information 
about the study are discussed below. You are urged to discuss any questions you have about this study with the staff 
members who explain it to you. 
We invite you to participate in a study of multiple treatments 
given in sequence to treat Chronic Myelogenous Leukemia (CML). 
These treatments will include Interferon injections, very high-dose 
chemotherapy, G-CSF administration, bone marrow and blood stem cell 
collection, high dose radiation and chemotherapy followed " by 
reinfusion of marrow and blood stem cells, further G-CSF 
administration, and maintenance treatment with Interferon. You were 
selected for this study because you are age 65 or younger and have 
Philadelphia chromosome positive CML either in 1st chronic phase or 
in advanced phase. The idea of this study is to induce remissions 
in CML patients by using multiple, intensive treatments designed to 
destroy as many of the leukemic cells as possible and to give your 
remaining normal non-leukemic cells a chance to regrow. 
You have a serious bone marrow disease called chronic 
myelogenous leukemia (CML). This is a cancer of a bone marrow cell 
called a "stem cell" that normally produces the white cells, red 
cells and platelets that circulate in the blood. The leukemic 
tumor cells have acquired an abnormal chromosome (the Philadelphia 
chromosome) that allows them to be easily distinguished from the 
normal cells in the bone marrow. In chronic phase, the CML stem 
cells produce too many white blood cells and often platelets. Mild 
chemotherapy drugs or interferon can decrease the counts to the 
normal range and allow patients with chronic phase CML to feel 
well and live relatively normal lives. However, an average of two 
CONSENT TO PARTICIPATE IN A CLINICAL 
RESEARCH STUDY 
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