Table 1.
Characteristics of patients according to pre-infusion tumor burden.
| Characteristics | Patients N=73 |
High disease burden N=39 |
Low disease burden N=34 |
P value |
|---|---|---|---|---|
| Age, years median (Range; percentile p25/75) | 10 (1-25; 6/14) | 8 (1–22, 5–10) | 10,5 (3–25, 8–17) | 0,004 |
| Previous allo-SCT n (%) | 33 (45) | 17 (43.6) | 16 (47.1) | 0,766 |
| Number of previous therapies, median (range) | 2.4 | 2.4 (0–5) | 2.4 (1–5) | |
| Previous blinatumomab n (%) | 5 (7) | 3 (7.5) | 2 (6) | |
| Bridging therapy n (%) | 0,05 | |||
| Chemotherapy | 61 (84) | 36 (93) | 25 (73) | |
| Inotuzumab | 12 (16) | 3 (7) | 9 (26.5) | |
| Extramedullary disease previous to CAR-T n (%) | 17 (23.3) | 6^ (15.4) | 11^^ (32.3) | 0.087 |
| % blasts at peripheral blood median (range) | 6.62 (0-94.4) | 12.56 (0-94.4) | 0 | 0.005 |
| Fulminant CRS n (%) | 2 (2.7) | 2 (5) | 0 | 0,49 |
| Progressive disease (< 28 days) n (%) | 5 (6.8) | 5 (13) | 0 | 0.03 |
| Loss of BCA n (%) | 26 (35.6) | 5 (19) | 21 (81) | 0,001 |
| Absolute B-lymphocytes count pre-lymphodepletion mean (CI 95%) | 127.3 [51-202] | 122 [23.8-221.49] | 133.24 [8.5-257] | 0,89 |
| Allo-SCT after CAR-T cell infusion n (%) | 0,056 | |||
| No | 47 (64) | 24 (61.5) | 23 (67.6) | |
| Yes: indicated due to loss of BCA | 6 (8.2) | 0 | 6 (17.6) | |
| Yes, indicated due to relapse | 15 (20) | 11 (28.2) | 4 (11.8) | |
| Yes, programmed based on a high pre-CAR T cell infusion risk profile* | 4 (5.5) | 3 (7.7) | 1 (2.9) |
Allo-SCT, allogenic stem cell transplantation.
CRS Cytokine-relapse syndrome.
^ 4 central nervous system, 1 testicular and 1 soft tissues.
^^ 7 central nervous system, 3 testicular and 1 parotid.
* Two patients with TP53 mutation and 2 patients with that information not available.