Clinical Data for TEL/AML1-Positive Children at Relapse Compared With TEL/AML1-Negative Patients With c- and Pre-B-ALL and All Negative Patients at Relapse
| Parameter . | TEL/AML1-Positive . | TEL/AML1-Negative Pre-B-/c-ALL . | Total . |
|---|---|---|---|
| Sex ratio (M:F), P = .99/.7 | 5:4 (1.25) | 12:10 (1.2) | 23:12 (1.9) |
| Age at diagnosis (yr),P = .86/.25 | |||
| n | 9 | 22 | 35 |
| Range | 3-13.94 | 0.7-15.6 | 0.7-16.3 |
| Median | 4.1 | 4.8 | 7.4 |
| WBC initial (×109/L),P = .99/.67 | |||
| n | 8 | 17 | 25 |
| Range | 5.6-84.9 | 2.5-79.4 | 2.5-96.8 |
| Median | 12.4 | 13.6 | 16.4 |
| Risk factor, P = .80/.87 | |||
| n | 5 | 13 | 21 |
| Range | 0.65-1.44 | 0.47-1.81 | 0.47-1.82 |
| Median | 1.05 | 1.07 | 1.07 |
| Risk | |||
| <0.8 | 2 | 2 | 3 |
| ≥0.8 | 3 | 11 | 18 |
| Coexpression at diagnosis, P = .68/.49 | |||
| None | 3 | 11 | 15 |
| 1 marker | 1 | 3 | 6 |
| 2 markers | 1 | 1 | 1 |
| Immunophenotype | |||
| Pro-B | 0 | 2 | |
| Pre-B | 1 | 4 | 4 |
| Common | 8 | 18 | 18 |
| T | 6 | ||
| Unknown | 5 | ||
| WBC relapse (×109/L),P = .88/.74 | |||
| n | 9 | 22 | 32 |
| Range | 3.1-12.4 | 0.8-23.2 | 0.7-77.5 |
| Median | 5.0 | 5.7 | 5.4 |
| Timepoint of relapse,P = .045/.041 | |||
| Very early | 0 | 6 | 11 |
| Early | 1 | 7 | 9 |
| Late | 8 | 9 | 15 |
| First CR (yr), P = .078/.046 | |||
| n | 9 | 22 | 35 |
| Range | 2.1-4.0 | 0.3-9.4 | 0.3-9.9 |
| Median | 3.1 | 2.3 | 2.3 |
| Second CR (yr) | |||
| n | 4 | 4 | 6 |
| Range | 3.2-5.5 | 0.2-4.2 | 0.2-4.2 |
| Median | 3.7 | 2.3 | 3.0 |
| Site of first relapse | |||
| BM | 7 | 11 | 22 |
| BM + CNS | 2 | 7 | 8 |
| BM + testis | 2 | 2 | |
| CNS | 1 | 1 | |
| Testis | 1 | 1 | |
| Unknown | 1 | ||
| Status, P = .31/.24 | |||
| Alive | 7 | 12 | 17 |
| CCR | 8 | 14 | |
| Dead | 2 | 2 | 4 |
| Parameter . | TEL/AML1-Positive . | TEL/AML1-Negative Pre-B-/c-ALL . | Total . |
|---|---|---|---|
| Sex ratio (M:F), P = .99/.7 | 5:4 (1.25) | 12:10 (1.2) | 23:12 (1.9) |
| Age at diagnosis (yr),P = .86/.25 | |||
| n | 9 | 22 | 35 |
| Range | 3-13.94 | 0.7-15.6 | 0.7-16.3 |
| Median | 4.1 | 4.8 | 7.4 |
| WBC initial (×109/L),P = .99/.67 | |||
| n | 8 | 17 | 25 |
| Range | 5.6-84.9 | 2.5-79.4 | 2.5-96.8 |
| Median | 12.4 | 13.6 | 16.4 |
| Risk factor, P = .80/.87 | |||
| n | 5 | 13 | 21 |
| Range | 0.65-1.44 | 0.47-1.81 | 0.47-1.82 |
| Median | 1.05 | 1.07 | 1.07 |
| Risk | |||
| <0.8 | 2 | 2 | 3 |
| ≥0.8 | 3 | 11 | 18 |
| Coexpression at diagnosis, P = .68/.49 | |||
| None | 3 | 11 | 15 |
| 1 marker | 1 | 3 | 6 |
| 2 markers | 1 | 1 | 1 |
| Immunophenotype | |||
| Pro-B | 0 | 2 | |
| Pre-B | 1 | 4 | 4 |
| Common | 8 | 18 | 18 |
| T | 6 | ||
| Unknown | 5 | ||
| WBC relapse (×109/L),P = .88/.74 | |||
| n | 9 | 22 | 32 |
| Range | 3.1-12.4 | 0.8-23.2 | 0.7-77.5 |
| Median | 5.0 | 5.7 | 5.4 |
| Timepoint of relapse,P = .045/.041 | |||
| Very early | 0 | 6 | 11 |
| Early | 1 | 7 | 9 |
| Late | 8 | 9 | 15 |
| First CR (yr), P = .078/.046 | |||
| n | 9 | 22 | 35 |
| Range | 2.1-4.0 | 0.3-9.4 | 0.3-9.9 |
| Median | 3.1 | 2.3 | 2.3 |
| Second CR (yr) | |||
| n | 4 | 4 | 6 |
| Range | 3.2-5.5 | 0.2-4.2 | 0.2-4.2 |
| Median | 3.7 | 2.3 | 3.0 |
| Site of first relapse | |||
| BM | 7 | 11 | 22 |
| BM + CNS | 2 | 7 | 8 |
| BM + testis | 2 | 2 | |
| CNS | 1 | 1 | |
| Testis | 1 | 1 | |
| Unknown | 1 | ||
| Status, P = .31/.24 | |||
| Alive | 7 | 12 | 17 |
| CCR | 8 | 14 | |
| Dead | 2 | 2 | 4 |
P values are given for TEL/AML1-positive v TEL/AML1-negative (pre-B/c-ALL)/TEL/AML1-positive v TEL/AML1-negative (total). The risk factor (RF) used for stratification in the therapy trial ALL-BFM is an estimation of the leukemic cell mass, and is calculated by the equation, RF = 0.2 × log (no. of blasts/μL) + 0.06 × liver (cm*) + 0.04 × spleen (cm*) (*below the costal margin).23