Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
neuroblastoma cells by ex vivo immunomagnetic purging; (ii) sensitive detection of 
relapse in transplanted patients; (iii) information on the source of the relapse; (iv) Hata 
indicating the potential clinical benefit of bone marrow purging. 
6.1.2 OBJECTIVES 
The proposed trial is a Phase 2 study that is intended to be used as a basis for the design 
of efficacy parameters for further Phase 3 studies. The following objectives will likely 
not be statistically validated by the proposed number of patients to be entered on this 
Phase 2 study. However, the outcome of the Phase 2 study will allow us to determine 
if the methods proposed here are useful for addressing these objectives in a Phase 3 study 
and to determine the number of patients that will be required to statistically validate the 
endpoints. 
The objectives of the study are: 
(1) to demonstrate the safety of the Neuroblastoma Bone Marrow Purging 
System for in vitro purging of bone marrow, 
(2) to demonstrate the clinical safety of the proposed gene marking and in 
vitro purging methods for evaluating the efficacy of purging, 
(3) to demonstrate the performance of the Neuroblastoma Bone Marrow 
Purging System, 
(4) to demonstrate the utility of gene marking for assessing the efficacy of 
purging, 
(5) to demonstrate the potential clinical benefit of bone marrow purging, and 
(6) to obtain data that will allow the design of additional studies to statistically 
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