The University of Texas 
M.D. ANDERSON CANCER CENTER 
INFORMED CONSENT 
PROTOCOL TITLE: Use of Retroviral Markers to Identify 
Efficacy of Purging and Origin of Relapse 
Following Autologous Bone Marrow 
Transplantation in Chronic Lymphocytic 
Leukemia (CLL) Patients 
1 . 
Participant's Name 
I.D. Number 
You have the right to know about the procedures that are to be 
used in your participation in clinical research so as to afford 
you an opportunity to make the decision whether or not to undergo 
the procedure after knowing the risks and hazards involved. This 
disclosure is not meant to frighten or alarm you; it is simply an 
effort to make you better informed so you may give or withhold 
your consent to participate in clinical research. This informed 
consent does not supersede other informed consents you may have 
signed . 
DESCRIPTION OF RESEARCH 
2. PURPOSE OF STUDY: This is a clinical research study at the 
M.D. Anderson Cancer Center with the following purposes: To 
identify the effectiveness of purging and to identify the 
origin of relapse which may eventually occur following 
restoration of marrow function with autologous cells (the 
patient's own cells) after high doses of chemotherapy and 
total body irradiation. 
3. DESCRIPTION OF RESEARCH: A decision has been made to 
undergo a course of intensive therapy followed by infusion 
of purged marrow cells (the patient's own). Although the 
use of intensive therapy has been associated with long term 
remission in some patients, relapse may occur in many cases. 
It is not yet known if the source of the leukemia cells 
which give rise to the relapse is from leukemia cells 
remaining in autologous peripheral blood and marrow (the 
patient's own) used for transplantation after therapy, or 
from leukemia cells which remain in the body after 
chemotherapy and irradiation. To answer this question, the 
cells stored from the marrow for transplantation may first 
be cleansed of leukemia cells. Then 30% of these cells will 
be genetically marked so as to determine if the relapse 
arises from the autologous marrow or from cells left in the 
body after therapy. This will help determine the best way 
to reduce the chance of relapse: increased intensity of 
systemic therapy versus more extensive cleansing procedures 
for the peripheral blood or marrow. 
Recombinant DNA Research, Volume 16 
[405] 
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