IUPUI INFORMED CONSENT STATEMENT 
for 
PROJECT Retroviral -Mediated Gene Transfer of Bone Marrow Celia During 
TITLE; Autologous Bone Marrow Transplantation for Acute 
1. I have been informed by my physician that I have acute leukemia. My 
physician and I have decided that autologous bone marrow transplantation 
is the treatment with the most potential for benefit at this stage in my 
disease. Autologous bone marrow transplantation and its risks have been 
explained to me, I have been asked to take part in a research study of 
"retroviral-mediated gene transfer" of bone marrow cells used during 
autologous bone marrow transplantation. 
Although treatment of leukemia by autologous bone marrow transplantation 
appears to be curative in some patients, I understand that the leukemia 
returns in others. Currently it is not known whether leukemia recurs due 
to leukemic cells present in the transplanted marrow or due to the 
inadequacy of chemotherapy treatments prior to transplantation in killing 
all the leukemia cells in the body. Development of a new technology has 
made it possible to mark the bone marrow cells given during transplantation 
so that they can be identified later in patients whose leukemia returns 
after transplantation. 
The new technology is called "retroviral-mediated gene transfer." It will 
insert a gene into some of my bone marrow cells at the time of 
transplantation. If my leukemia returns after transplantation, and 
contains the inserted gene, we would know that the contributing reason for 
failure of the transplant was leukemia in the marrow harvested and infused 
during the transplant. If the gene is not present, the reason for the 
failure could be leukemia cells that were not killed off by the 
chemotherapy prior to the transplantation procedure. Once the reasons why 
some patients relapse after bone marrow transplantation are better 
understood, better ways of performing transplantations could be tested. 
I understand that the introduction of this gene will not benefit mo in any 
way. It is possible that this study may lead to improved bone marrow 
transplantation therapies for others in the future. It may also be 
possible, however, that no new information will be obtained. The purpose 
of the study is to assess the safety of this procedure and to determine 
if "retroviral-mediated gene transfer" will enable the physicians to 
determine the source of leukemia recurrence. 
2. If I decide to participate in this study, a special laboratory technique 
will be used to Insert a gene into a portion of my bone marrow cells after 
being harvested. These treated bone marrow cells are referred to as 
"marked" bone marrow cells. A gene is part of a chromosome (the part of 
the cell that is inherited from someone's parents) that contains the 
information a cells needs to make proteins. By inserting a gene into my 
bone marrow cells, the investigator will be able to distinguish the marked 
bone marrow cells from all other cells in my body. 
Patient's Initials 
Recombinant DNA Research, Volume 15 
[ 503 ] 
