Study Treatment Groups
Treatment Group . | Dose of SCF (μg/kg/d) . | Dose of Filgrastim (μg/kg/day) . | Duration of Dosing (μg/kg/d) . | Leukapheresis . | No. of Leukapheresis Products Infused* . | No. of Patients . |
---|---|---|---|---|---|---|
. | . | . | . | (day of collection phase) . | . | . |
A | 0 | 10 | 7 | 5-7 | 3 | 35 |
B | 0 | 10 | 7 | 5-7 | 1 | 7 |
C | 10 | 10 | 7 | 5-7 | 3 | 25 |
D | 15 | 10 | 7 | 5-7 | 3 | 15 |
E | 20 | 10 | 7 | 5-7 | 3 | 27 |
F | 20 | 10 | 7 | 5-7 | 1 | 8 |
G | 25 | 10 | 7 | 5-7 | 1 | 9 |
H | 30 | 10 | 7 | 5-7 | 1 | 3 |
I | 20 | 10 | 10 | 8-10 | 3 | 15 |
J | 5 | 10 | 13 | 11-13 | 3 | 6 |
K | 10 | 10 | 13 | 11-13 | 3 | 11 |
L | 15 | 10 | 13 | 11-13 | 3 | 12 |
M | 20 | 10 | 13 | 11-13 | 3 | 11 |
N | 5 | 0 | 13 | 11-13 | 3 | 5 |
189 (Total) |
Treatment Group . | Dose of SCF (μg/kg/d) . | Dose of Filgrastim (μg/kg/day) . | Duration of Dosing (μg/kg/d) . | Leukapheresis . | No. of Leukapheresis Products Infused* . | No. of Patients . |
---|---|---|---|---|---|---|
. | . | . | . | (day of collection phase) . | . | . |
A | 0 | 10 | 7 | 5-7 | 3 | 35 |
B | 0 | 10 | 7 | 5-7 | 1 | 7 |
C | 10 | 10 | 7 | 5-7 | 3 | 25 |
D | 15 | 10 | 7 | 5-7 | 3 | 15 |
E | 20 | 10 | 7 | 5-7 | 3 | 27 |
F | 20 | 10 | 7 | 5-7 | 1 | 8 |
G | 25 | 10 | 7 | 5-7 | 1 | 9 |
H | 30 | 10 | 7 | 5-7 | 1 | 3 |
I | 20 | 10 | 10 | 8-10 | 3 | 15 |
J | 5 | 10 | 13 | 11-13 | 3 | 6 |
K | 10 | 10 | 13 | 11-13 | 3 | 11 |
L | 15 | 10 | 13 | 11-13 | 3 | 12 |
M | 20 | 10 | 13 | 11-13 | 3 | 11 |
N | 5 | 0 | 13 | 11-13 | 3 | 5 |
189 (Total) |
An additional 26 patients who were mobilized to a target CD34+ cell yield received cytokine for 5 to 9 days; 13 received 15 μg/kg/d SCF and 10 μg/kg/d filgrastim and 13 received 10 μg/kg/d filgrastim alone. In total, 189 patients were evalueated for efficacy and 215 for safety.
Patients receiving only 1 leukapheresis product back were infused the first product collected.