be eligible for alternative therapy at the discretion 
of the referring physician. Patients will continue to 
be monitored for any adverse effects of the marking 
vectors . 
14 . 3 Location of a compatible donor and proceeding to 
allogeneic marrow transplant. 
15.0 Biostatistical Analysis 
15.1 Evaluation of Clinical/Cytogenetic Response to 
Treatment Process: 
Continued study of this treatment approach is 
warranted if this study shows a major cytogenetic 
remission rate sustained for at least 6 months in > 30% 
of patients. Initially, 15 patients will be studied. If 
< 2 patients meet these criteria, the study would 
close. If > 3 patients achieve major remission, a total 
of 25 patients would be studied. Under these conditions 
there is a 90% probability that the study will continue 
with a true response rate not less than 10% and 90% 
probability that a response of > 30% is rejected in 
this program. An accrual of 15 patients per year 
between centers is anticipated. 
All patients will be evaluable 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. 
Recombinant DNA Research, Volume 16 
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