E. Post Marrow Transplantation (day 21 to dav 281 
1. As long as patient is in the hospital, perform steps D.2 to D.4 above. 
2. If patient is discharged from the hospital before day 28 , measure 
temperature, hematologic assays and clinical evaluation at least 3x/week 
unless patients* condition requires more frequent assays. 
F. Post Marrow Transplantation (day 28 to day 100. end of study) 
1. While patient is still in the hospital, unless patients’ condition requires 
greater frequency: 
a) Vital signs daily. 
b) 3x/week cellular hematologic assays and clinical evaluations. 
c) Once/week perform clinical laboratory safety assessment and blood 
cultures. (Repeat culture if positive). 
2. Once discharged from hospital, unless patients* condition requires a greater 
frequency: 
a) Vital signs, cellular hematologic assays and clinical evaluation 
3x/week until day 35, then once/week. 
b) Bone marrow assays on day 56. 
G. At the End of the Study (DAY 100) 
Record engraftment status, relapse, survival. 
H. At 1 Year Posttransplantation: 
Record engraftment status, relapse, survival. 
L Special Procedures 
Baseline laboratory (pretreatment tests). 
1. Vital signs. 
Z Hematologic assays: CBC; differential; preplatelet count; and reticulocyte 
count 
3. Cultures: blood, stool, urine, and throat for pathogenic bacteria, viruses 
and fungi. 
4. FH1 (electrolytes, glucose, BUN, creatinine) F II (Calcium, phosphorus, 
albumin, magnesium), F DI (bilirubin, alkaline phosphatase, liver enzymes) 
5. Viral infection status: HIV, HSsAg, and antibody titers for cytomegalovirus 
(CMV) and toxoplasmosis. 
- 6. Bone marrow biopsy and aspiration. 
7. Chest x-ray. 
8. EKG. 
Definition and Measurement of Toxicity 
A. Toxicity related to rhIL3 is minimal. No life threatening toxicides have been 
identified in over 50 patients at doses similar to those defined in this study. 
Minor toxicides in occasional patients have included low grade temperature 
Recombinant DNA Research, Volume 16 
[335] 
