Table of Contents 
Schema 
1.0 
Objectives 
4 
2.0 
Background 
4 
3.0 
Patient Eligibility 
15 
4.0 
Pretreatment Evaluation 
16 
5.0 
Bone Marrow Harvest 
17 
6.0 
Treatment Plan 
19 
7.0 
Retroviral Transfection Procedure 
and Separation of CD34+ Population 
25 
8.0 
Pharmaceutical Information 
26 
9.0 
Drug Toxicity 
28 
10.0 
Dose Modifications 
29 
11.0 
On Study Evaluation 
30 
12.0 
Statistical Considerations 
32 
13.0 
Reporting of Adverse Drug Reactions 
33 
14.0 
Response Criteria 
34 
15.0 
References 
35 
Appendix 1 - Common Toxicity Criteria 
Appendix II - ABMT Toxicity Criteria 
Appendix III - Letter to FDA 
Recombinant DNA Research, Volume 16 
