Clinical characteristics and outcome of patients included in the GMALL MRD trials
Variable . | GMALL 05/93 MRD pilot trial . | GMALL 06/99 . |
|---|---|---|
| Total no. patients | 65 | 196 |
| Sex, no. (%) | ||
| Male | 43 (66) | 125 (64) |
| Female | 22 (34) | 71 (36) |
| Median age, y (range) | 35 (16-66) | 30 (15-64) |
| No. patients (%) | ||
| Younger than 35 y | 32 (49) | 121 (62) |
| 35 y and older | 33 (51) | 75 (38) |
| Median WBC count, × 109/L, (range)* | 17.6 (1.7-338) | 8.9 (0.86-731.1) |
| No. patients with WBC count (%) | ||
| Less than 30 × 109/L | 36 (60) | 153 (81) |
| 30 × 109/L or more | 24 (40) | 36 (19)† |
| Immunophenotype, no. (%) | ||
| B-lineage | 52 (80) | 124 (63) |
| T-lineage | 13 (20) | 72 (37) |
| Presence of adverse prognostic factors, no. (%) | 27 (42)‡ | 0 (0)§ |
Variable . | GMALL 05/93 MRD pilot trial . | GMALL 06/99 . |
|---|---|---|
| Total no. patients | 65 | 196 |
| Sex, no. (%) | ||
| Male | 43 (66) | 125 (64) |
| Female | 22 (34) | 71 (36) |
| Median age, y (range) | 35 (16-66) | 30 (15-64) |
| No. patients (%) | ||
| Younger than 35 y | 32 (49) | 121 (62) |
| 35 y and older | 33 (51) | 75 (38) |
| Median WBC count, × 109/L, (range)* | 17.6 (1.7-338) | 8.9 (0.86-731.1) |
| No. patients with WBC count (%) | ||
| Less than 30 × 109/L | 36 (60) | 153 (81) |
| 30 × 109/L or more | 24 (40) | 36 (19)† |
| Immunophenotype, no. (%) | ||
| B-lineage | 52 (80) | 124 (63) |
| T-lineage | 13 (20) | 72 (37) |
| Presence of adverse prognostic factors, no. (%) | 27 (42)‡ | 0 (0)§ |
Exact white-blood cell (WBC) count was available for 60 of 65 GMALL 05/93 patients and 189 of 196 GMALL 06/99 patients
All patients with a WBC count greater than 30 × 109/L had a T-lineage ALL, as in B-lineage ALL a WBC count greater than 30 × 109/L was defined as adverse prognostic factor
Adverse prognostic factors were: subtype of a pro-B-ALL (n = 6), presence of a t(9;22)/BCR-ABL (n = 14) or a t(4;11)/MLL-AF4 (n = 2) (cytogenetic/molecular data available for 45 patients), WBC count greater than 30 × 109/L in B-lineage ALL (n = 12)
Absence of adverse prognostic factors was the precondition for inclusion into GMALL 06/99 MRD SR trial