probability of 90% even if only 100 cells contribute to the relapse. In any one 
individual, there is a >60% chance of detecting a marked relapse if 1000 cells 
contribute, and >95% chance if 3000 cells contribute. 
8.2 Transduction of Normal Progenitors 
Because the probability of transducing a human stem cell in a patient 
recovering from chemotherapy is unknown (see Appendix A) and because the 
number of pluripotent stem cells contributed by an autologous marrow graft 
is unknown, it is not possible to assess the number of patients required to 
undertake this subsidiary aim. But if transduction into early progenitors is 
possible, then data on the value of this approach for investigating stimuli which 
modify progenitor behavior could readily be obtained within the first 12 
patients, since even a single positive patient would be informative. Should the 
first 12 patients show no evidence of early progenitor marking, this component 
of the study would not be continued separately from the primary aim of 
analyzing the source of relapse. 
8.3 Statistical Considerations for Evaluation of ABMT as Therapy 
We expect to accrue 12 to 14 patients per year on this study. We intend to 
compare the percentage of patients remaining in hematologic remission at 3 
years with 60 historical controls receiving the same chemotherapy regimen for 
remission induction. The expected percentage of patients remaining in 
remission at 3 years in the historical group is «75%. To detect an increased 
survival at 3 years of 30% with an 80% probability and 95% confidence will 
require «30 patients. The drug/ABMT combination will be considered 
effective if and only if we were able to produce a 30% or greater projected 
disease free survival at 3 years. 
9.0 DRUG INFORMATION 
9.1 Carboplatin (CBDCA) NSC #241240 
It is a bifunctional alkylating agent and is non-phase specific. Carboplatin 
appears to bind to cellular replicating DNA and to alter the superhelical 
conformation resulting in single strand breaks. The half-life of total and of 
free platinum is 306 times longer after carboplatin than it is after cisplatin. 
The drug is commercially available and supplied in 20 ml vials containing 150 
mg of carboplatin prepared as a white lyophilized powder and 150 mg of 
mannitol. Intact vials should be stored under refrigeration (2-8 “C) and 
reconstituted with 9.8 ml sterile water, each ml containing 15 mg carboplatin 
and 15 mg mannitol at pH 4.5-7.0. When reconstituted as directed, the 
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