Table 2 Treatment outcomes
N, (%) | Total |
|---|---|
Study completion | |
Cycle 3 | 25/32 (78.1) |
Cycle 8 | 7/32 (21.9) |
Reasons for no completing the study | |
Progression | 19/25 (76.0) |
Death | 2/25 (8.0) |
Others | 4/25 (16.0) |
Consent withdrawal | 1 |
For additional treatment | 3 |
Best response during the study | |
sCR + CR | 11/31 (35.5) |
VGPR | 3/31 (9.7) |
PR | 7/31 (22.6) |
SD | 7/31 (22.6) |
PD | 3/31 (9.7) |
ORR (sCR + CR + VGPR + PR) | 21/31 (67.7) |
NE | 1 |
DCEP dose reductions | |
Cycle 1 (N = 32) | Full dose 9/32 (28.1%); planned 30% DR 23/32 (71.9%) |
Cycle 2 (N = 29) | Same dose as Cycle 1 25/29 (86.2%); dose reduction from Cycle 1 2/29 (6.9%)*; dose escalation from Cycle 1 2/29 (6.9%) |
Cycle 3 (N = 25) | Same dose as Cycle 2 25/25 (100%) |
DCEP dose delays | |
Cycle 2 (N = 29) | 4 (13.8) |
Cycle 3 (N = 25) | 3 (12.0) |
ASCT during clinical trial | 2/32 (6.3) |
History of prior ASCT | 1 |
Infused CD34 cells, × 106/kg, median (range) | 4.53 (3.3.41–5.65) |
Conditioning regimen | |
Melphalan 200 mg/m2 | 2 |