a true response rate not less than 10% and a 90% 
probability that a' response rate of > 30% would not be 
rejected in this program. An accrual of 15 patients per 
year between centers is anticipated. 
All patients "will be ~eva2ruable for response;- -■ 
potentially at multiple points. All patients will be 
available for toxicity . 'Patients ‘who die during therapy 
or who are lost to follow-up will be counted as having 
progressed as of that date unless there is definite * 
clinical or autopsy diagnosis of death due to an 
unrelated cause. 
15.2 Evaluation of Toxicity, Disease-free Survival, 
Progression-free Survival: 
Incidence of toxicities will be reported. Disease-free 
survival and progression-free survival will be 
calculated by Kaplan-Meier analysis. 
15.3 Hematologic Recovery Post-transplant: 
The number of days to resolution of severe neutropenia 
(>100, 500, 1,000, 1,500/cu. mm.) and thrombocytopenia 
(> 50,000, 100 , 000/cu. mm., unrelated to transfusions) 
will be determined. For platelet counts the day of 
recovery is recorded if a particular value is equaled 
or exceeded on two consecutive days without platelet 
transfusions. Patients who are discharged prior to 
complete hemopoietic recovery have counts measured as 
outpatients 2-3 times per week until recovery exceeds 
1500/cu mm granulocytes and 100, 000/cu mm platelets. 
Probability of recovery to each level is calculated 
using Kaplan-Meier survival analysis. 
Recombinant DNA Research, Volume 16 
[61] 
