Outcome 3 would indicate that a significant proportion of acute myeloid 
leukemias are in fact stem cell disorders and that in these patients current 
chemotherapeutic and autografting strategies are unlikely to make any further 
impact on their survival. 
7.2 Stem Cell Marking 
Analysis of the stimuli required in vivo to induce stem cells into qrcle, and to 
induce proliferation of cells of different lineages would greatly simplify efforts 
to grow adequate marrow in vitro from small aliquots for successful 
subsequent ABMT. Moreover an indication of the cytoldnes responsible for 
hemopoeitic precursor or stem cell cycling would help in planning more 
effective chemotherapy and in optimising the timing of marrow harvest for 
subsequent storage and re-infusion. 
8.0 STUDY SIZE AND STATISTICAL CONSIDERATIONS 
8.1 The autologous BMT clinical results will be analyzed permitting no more than 
25% of the patients to experience unacceptable toxicity and no more than 15% 
death during the transplant. Using a significance test of a = 0.25 we will use 
the following table. 
Number of 
Re-evaluate if the 
Re-evaluate if number 
patients treated 
number of "failure” 
of unacceptable toxicity 
with each cycle 
exceeds 
in the cycle exceeds 
6 
1 
2 
7 
2 
2 
8-10 
2 
3 
11 
2 
4 
12- 13 
3 
4 
14 - 17 
3 
5 
18-20 
4 
6 
*Failure is defined as death before the completion of the transplant. 
At least 12 newly diagnosed patients with AML in first CR will enter this 
study per year and therefore, we would expect to accrue a minimum of 48 
patients in 4 years. We intend to compare the percentage of patients 
remaining in hematologic remission at two years with 120 historical controls 
of the past two AML studies (n=60 for AML80 and n=63 for AML-83). The 
Recombinant DNA Research, Volume 14 
[517] 
