CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study 
STUDY NUMBER: 
CONTINUATION: oaoe 2 nf 14 _ pages 
to four years after diagnosis of CML patients develop first an 
"accelerated phase" and then a "blast crisis" when the bone marrow 
and circulating blood becomes filled with very immature leukemic 
cells called blasts that crowd out any remaining normal cells and 
may cause many serious medical problems. Once CML patients reach 
blast crisis, even very high-dose chemotherapy fails to put them 
back into chronic phase or remission for more than a few months, 
and patients die of infection, uncontrolled leukemia or bleeding. 
The only form of treatment that has thus far been proven to 
cure patients with CML is a bone marrow transplant from another 
person (an "allogeneic" transplant). But this type of 
transplantation is limited to patients that have a genetically 
matched donor in their family or in the unrelated bone marrow donor 
registry, and is a very risky procedure, especially in older 
patients. 
The other type of transplantation that has been used in CML is 
"autologous" transplantation. In this type of transplantation 
cells are collected from from either the bone marrow or peripheral 
blood of the CML patient while they are in chronic phase and 
reinfused after very high dose chemotherapy and radiation. CML 
stem cells may not survive the transplantation procedure as weli. as 
any remaining normal marrow cells, allowing some patients to 
recover after transplantation with normal marrow cells instead of 
leukemic cells. This type of treatment has been associated with 
long-term remission in some CML patients, but it is not yet clear 
if any patients treated in this way have been cured. Many patients 
treated in this way do relapse at a later time. We hope that by 
combining additional treatments with the high dose therapy followed 
by autologous stem cell transplant we can increase the chances of 
patients with CML going into long term remission or cure. 
Patients in 1st chronic phase will be classified as Group 1 
patients and patients with advanced disease (blast crisis, 
accelerated phase, or chronic phase after prior blast crisis) will 
be classified as Group 2. You are in Group . 
This protocol involves a long sequence of different types of 
treatments. These are described below in the the order you will 
receive them. 
VT1ENT IDENTIFICATION 
CONTINUATION SHEET for either: 
Recombinant DNA Research, Volume 16 
[181] 
6p O »l I -32t 
I 
