MRD-negativity rates and summary of allogeneic HSCT for T-cell ALL/LL cohorts
| . | Childhood T-cell ALL (n = 24) . | Young adult T-cell ALL (n = 5) . | Pooled T-cell ALL (n = 29) . | T-cell LL (n = 10)∗ . |
|---|---|---|---|---|
| MRD-negativity rate, n (%)∗[90% CI†] | ||||
| End of cycle 1‡ | 7 (29.2) [14.6-47.9] | 0 | 7 (24.1) [11.9-40.6] | 5 (50.0) [22.2-77.8] |
| End of cycle 2‡ | 2 (8.3) [1.5-24.0] | 1 (20.0) [1.0-65.7] | 3 (10.3) [2.9-24.6] | 0 |
| After treatment§ | 1 (4.2) [0.2-18.3] | 0 | 1 (3.4) [0.2-15.3] | 0 |
| At any time | 11 (45.8) [28.2-64.2]‖ | 1 (20.0) [1.0-65.7] | 12 (41.4) [25.9-58.3]‖ | 5 (50.0) [22.2-77.8] |
| Allogeneic HSCT rate, n (%) [90% CI†] | 18 (75.0) [56.5-88.5] | 3 (60.0) [18.9-92.4] | 21 (72.4) [55.7-85.5] | 3 (30.0) [8.7-60.7] |
| Number of CD34+ cells transplanted, median (range), 106/kg | 5.3 (0.5-264.0) | 4.6 (1.2-10.0) | 5.0 (0.5-264.0) | 3.7 (3.2-7.3) |
| Source of CD34+ cells transplanted, n (%)¶ | ||||
| Cord blood | 2 (11.1) | 0 | 2 (9.5) | 1 (33.3) |
| Peripheral blood | 7 (38.9) | 2 (66.7) | 9 (42.9) | 1 (33.3) |
| Bone marrow | 9 (50.0) | 1 (33.3) | 10 (47.6) | 1 (33.3) |
| Time to engraftment, median (range), d | 18.0 (10-34) | 26.0 (21-31) | 19.0 (10-34) | 20.0 (11-23) |
| . | Childhood T-cell ALL (n = 24) . | Young adult T-cell ALL (n = 5) . | Pooled T-cell ALL (n = 29) . | T-cell LL (n = 10)∗ . |
|---|---|---|---|---|
| MRD-negativity rate, n (%)∗[90% CI†] | ||||
| End of cycle 1‡ | 7 (29.2) [14.6-47.9] | 0 | 7 (24.1) [11.9-40.6] | 5 (50.0) [22.2-77.8] |
| End of cycle 2‡ | 2 (8.3) [1.5-24.0] | 1 (20.0) [1.0-65.7] | 3 (10.3) [2.9-24.6] | 0 |
| After treatment§ | 1 (4.2) [0.2-18.3] | 0 | 1 (3.4) [0.2-15.3] | 0 |
| At any time | 11 (45.8) [28.2-64.2]‖ | 1 (20.0) [1.0-65.7] | 12 (41.4) [25.9-58.3]‖ | 5 (50.0) [22.2-77.8] |
| Allogeneic HSCT rate, n (%) [90% CI†] | 18 (75.0) [56.5-88.5] | 3 (60.0) [18.9-92.4] | 21 (72.4) [55.7-85.5] | 3 (30.0) [8.7-60.7] |
| Number of CD34+ cells transplanted, median (range), 106/kg | 5.3 (0.5-264.0) | 4.6 (1.2-10.0) | 5.0 (0.5-264.0) | 3.7 (3.2-7.3) |
| Source of CD34+ cells transplanted, n (%)¶ | ||||
| Cord blood | 2 (11.1) | 0 | 2 (9.5) | 1 (33.3) |
| Peripheral blood | 7 (38.9) | 2 (66.7) | 9 (42.9) | 1 (33.3) |
| Bone marrow | 9 (50.0) | 1 (33.3) | 10 (47.6) | 1 (33.3) |
| Time to engraftment, median (range), d | 18.0 (10-34) | 26.0 (21-31) | 19.0 (10-34) | 20.0 (11-23) |
CI, confidence interval.
MRD-negativity rates were calculated with the number of patients who were MRD negative as the numerator and the number of patients in the all-treated analysis set as the denominator. In T-cell LL cohort, bone marrow evaluation was only required if bone marrow disease was present at study entry; of 5 patients with bone marrow involvement (≥5% bone marrow blasts) at baseline, 3 patients achieved MRD negativity during the study.
90% CIs are based on the Clopper-Pearson exact test.
Rates in cycle 1 and cycle 2 are mutually exclusive.
Assessed before the initiation of subsequent treatment and/or HSCT.
One patient with childhood T-cell ALL had an unscheduled MRD assessment on day 1 of cycle 3. This patient was included in the count for “at any time” but was not included in the end of cycle 1, end of cycle 2, or posttreatment counts.
Percentages were calculated with the number of patients who had CD34+ cells sourced from the indicated tissue type as the numerator and the number of patients who underwent allogeneic HSCT as the denominator.