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TABLE OF CONTENTS (CONT.) 
7.0 CRITERIA FOR DISCONTINUATION OF STUDY PATIENTS 28 
7.1 Criteria for Treatment Discontinuation 28 
7.2 Criteria for Study Discontinuation 28 
8.0 ADVERSE EXPERIENCES 29 
Appendix III is Adverse Experience Reporting 
9.0 EVALUATION OF RESPONSE/ENDPOINTS 29 
10.0 DOCUMENTATION, RECORD KEEPING, CRFs 30 
11.0 DATA COLLECTION AND STUDY MONITORING 31 
12.0 BIOST ATISTIC AL CONSIDERATIONS 31 
13.0 ETHICAL CONSIDERATIONS 31 
13.1 Informed Consent 31 
Appendix IV are the Patient Informed Consent(s) 
13.2 Patient Confidentiality 32 
14.0 CRITERIA AND PROCEDURES FOR PROTOCOL MODIFICATION 
AND STUDY TERMINATION 32 
15.0 PUBLICATION OF RESEARCH FINDINGS 
PROTECTION OF COMPANY TRADE SECRETS 32 
16.0 BIOHAZARD WARNINGS AND PRECAUTIONS 32 
17.0 REFERENCES 33 
APPENDICES : 
IA EVALUATIONS TABLE (Bone Marrow Harvest Patients) 
IB EVALUATIONS TABLE (Peripheral Blood Stem Cell Harvest Patients) 
H TOXICITY GRADING TABLE 
HI ADVERSE EXPERIENCES REPORTING GUIDELINES 
IV KARNOFSKY PERFORMANCE SCALE 
V ADDITIONAL DRUG INFORMATION 
VI TRANSDUCTION OF HUMAN HEMATOPOIETIC PROGENITOR CELLS 
VII CERTIFICATE OF ANALYSIS - TRANSDUCED MARROW CELLS 
VIII PATIENT INFORMED CONSENT(S) 
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