The University of Texas 
M.D. ANDERSON CANCER CENTER 
INFORMED CONSENT 
PROTOCOL TITLE: Use of Retroviral Markers to Test Relative 
Contribution of Marrow and Peripheral Blood 
Autologous Cells to Recovery after Preparative 
Therapy 
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 with the 
following purpose: To genetically mark peripheral blood and 
marrow cells in order 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 cyclophosphamide, VP-16, and total body irradiation 
and to determine the relative contribution of marrow and 
peripheral blood cells to hematopoietic recovery after 
transplantation. This program will also determine the types 
of failure which may occur in this therapy (failure to 
eradicate disease and failure to recover marrow function) . 
3. DESCRIPTION OF RESEARCH: A decision has been made to undergo 
a course of intensive therapy followed by infusion of 
autologous peripheral blood and 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 peripheral blood and 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 peripheral 
blood or marrow or from cells left in the body after therapy. 
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Recombinant DNA Research, Volume 15 
