Clinical characteristics of the patients belonging to the 2 arms of the study
| . | Cs-A Dose . | P Value . | |
|---|---|---|---|
| 1 mg/kg/d . | 3 mg/kg/d . | ||
| Cs-A1 group . | Cs-A3 group . | ||
| No. of patients | 30 | 29 | |
| ALL | 24 | 23 | |
| 1st CR | 10 | 5 | |
| 2nd CR | 13 | 15 | NS |
| 3rd CR | 1 | 3 | |
| AML | 6 | 6 | |
| 1st CR | 6 | 3 | NS |
| 2nd CR | 0 | 3 | |
| ALL immunophenotype | |||
| Common | 15 | 13 | |
| Pre-B | 3 | 5 | |
| B | 0 | 1 | NS |
| Early-T | 4 | 2 | |
| T | 2 | 2 | |
| AML FAB | |||
| M0 | 1 | 0 | |
| M1 | 0 | 2 | |
| M3 | 1 | 2 | NS |
| M4 | 1 | 0 | |
| M5 | 2 | 2 | |
| M6 | 1 | 0 | |
| WBC at diagnosis (× 109/L) | 38 (0.5-532) | 24 (0.9-750) | NS |
| Cytogenetics | |||
| Unfavorable | 5 | 2 | |
| Intermediate | 21 | 24 | NS |
| Favorable | 4 | 3 | |
| Extramedullary disease at diagnosis (Yes/No) | 4 | 3 | NS |
| Interval diagnosis—1st CR (d) | 41 (15-126) | 42 (13-97) | NS |
| Interval last CR—BMT (mo) | 3 (1-11) | 2.5 (0.5-13) | NS |
| First relapse | |||
| On therapy | 4 | 6 | NS |
| Off therapy | 10 | 15 | |
| Recipient | |||
| Sex (M/F) | 15/15 | 18/11 | NS |
| Age at diagnosis (years) | 4 (0.5-16) | 7 (1.4-14) | NS |
| Age at BMT (years) | 7 (0.9-17) | 9 (1.8-18) | NS |
| Donor | |||
| Sex (M/F) | 16/14 | 17/12 | NS |
| Age (years) | 11 (1-21) | 7 (1-25) | NS |
| Sex match | 17 | 14 | |
| Sex mismatch | |||
| M → F | 7 | 7 | NS |
| F → M | 6 | 8 | |
| Conditioning regimen | |||
| TBI + Thio + Cy | 14 | 15 | |
| TBI + VCR + Cy | 7 | 7 | NS |
| Bu + Cy + Melphalan | 9 | 7 | |
| Number of cells infused (× 108/Kg) | 3.4 (0.3-7.6) | 3.2 (0.2-9.0) | NS |
| G-CSF after BMT (yes/no) | 25/5 | 20/9 | NS |
| . | Cs-A Dose . | P Value . | |
|---|---|---|---|
| 1 mg/kg/d . | 3 mg/kg/d . | ||
| Cs-A1 group . | Cs-A3 group . | ||
| No. of patients | 30 | 29 | |
| ALL | 24 | 23 | |
| 1st CR | 10 | 5 | |
| 2nd CR | 13 | 15 | NS |
| 3rd CR | 1 | 3 | |
| AML | 6 | 6 | |
| 1st CR | 6 | 3 | NS |
| 2nd CR | 0 | 3 | |
| ALL immunophenotype | |||
| Common | 15 | 13 | |
| Pre-B | 3 | 5 | |
| B | 0 | 1 | NS |
| Early-T | 4 | 2 | |
| T | 2 | 2 | |
| AML FAB | |||
| M0 | 1 | 0 | |
| M1 | 0 | 2 | |
| M3 | 1 | 2 | NS |
| M4 | 1 | 0 | |
| M5 | 2 | 2 | |
| M6 | 1 | 0 | |
| WBC at diagnosis (× 109/L) | 38 (0.5-532) | 24 (0.9-750) | NS |
| Cytogenetics | |||
| Unfavorable | 5 | 2 | |
| Intermediate | 21 | 24 | NS |
| Favorable | 4 | 3 | |
| Extramedullary disease at diagnosis (Yes/No) | 4 | 3 | NS |
| Interval diagnosis—1st CR (d) | 41 (15-126) | 42 (13-97) | NS |
| Interval last CR—BMT (mo) | 3 (1-11) | 2.5 (0.5-13) | NS |
| First relapse | |||
| On therapy | 4 | 6 | NS |
| Off therapy | 10 | 15 | |
| Recipient | |||
| Sex (M/F) | 15/15 | 18/11 | NS |
| Age at diagnosis (years) | 4 (0.5-16) | 7 (1.4-14) | NS |
| Age at BMT (years) | 7 (0.9-17) | 9 (1.8-18) | NS |
| Donor | |||
| Sex (M/F) | 16/14 | 17/12 | NS |
| Age (years) | 11 (1-21) | 7 (1-25) | NS |
| Sex match | 17 | 14 | |
| Sex mismatch | |||
| M → F | 7 | 7 | NS |
| F → M | 6 | 8 | |
| Conditioning regimen | |||
| TBI + Thio + Cy | 14 | 15 | |
| TBI + VCR + Cy | 7 | 7 | NS |
| Bu + Cy + Melphalan | 9 | 7 | |
| Number of cells infused (× 108/Kg) | 3.4 (0.3-7.6) | 3.2 (0.2-9.0) | NS |
| G-CSF after BMT (yes/no) | 25/5 | 20/9 | NS |
Data are expressed as median and range. P values were calculated using Mann-Whitney rank-sum test, Student's t test, χ2 test, or Fisher exact test, as appropriate. TBI indicates total-body irradiation; Thio, thiotepa; Cy, cyclophosphamide; VCR, vincristine; Bu, busulfan; G-CSF, granulocyte-colony stimulating factor; WBC, white blood cell count.