The University of Texas 
M.D. ANDERSON CANCER CENTER 
INFORMED CONSENT 
PROTOCOL TITLE: Autologous Bone Marrow Transplantation for CML 
in VThich Retroviral Markers are Used to 
Discriminate Between Relapse Which Arises from 
Systemic Disease Remaining After Preparative 
Therapy Versus Relapse Due to Residual 
Leukemic Cells in Autologous Marrow: A Pilot 
Trial 
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 to 
reinduce remissions in CML with intensive therapy and to 
identify the origin of relapse which may eventually occur 
following restoration of marrow function with autologous cells 
after high doses of cyclophosphamide, VP-16, and total body 
irradiation. 
3. DESCRIPTION OF RESEARCH: Although the use of intensive 
therapy and autologous stem cells, which are given as part of 
this protocol, have been associated with long term remission 
in some patients, this is not always the case. It is not yet 
known if the source of the leukemia cells which give rise to 
the relapse is from leukemia cells remaining in the autologous 
marrow used for transplantation after therapy, or from 
leukemia cells which remain in the body after chemotherapy and 
irradiation. To answer this question, 30% of the cells in 
the autologous marrow transplantation will be tagged with a 
DNA molecule 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 autologous 
marrow. 
Autologous cells will be used to restore normal marrow 
function after intensive therapy. Patients will have bone 
marrow stored (about two quarts) from the pelvis and possible 
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Recombinant DNA Research, Volume 14 
