Table 1.
Baseline patient, disease, and infusion characteristics for patients receiving tisagenlecleucel via the MAP/IND or SOC
| MAP/IND (n = 24) | SOC (n = 161) | P | |
|---|---|---|---|
| Age at diagnosis, median (range), y | 6 (0-22) | 8 (0-25) | .40 |
| Age at infusion, median (range), y | 10.5 (0-25) | 13 (0-26) | .49 |
| Females/males | 8 (33.3)/16 (66.7) | 66 (41.0)/95 (59.0) | .48 |
| Race | |||
| Non-Hispanic/White | 10 (41.7) | 80 (49.7) | .30 |
| Hispanic/Black | 10 (41.7) | 67 (41.6) | |
| Asian | 2 (8.3) | 5 (3.1) | |
| Multiracial/unknown/not reported | 2 (8.3) | 9 (5.6) | |
| Leukemia cytogenetics | |||
| Unfavorable | 7 (29.2) | 53 (32.9) | .90 |
| Hypodiploid | 1 (4.2) | 6 (3.7) | |
| t(9;22)/Ph-like | 3 (12.5) | 26 (16.1) | |
| KMT2A rearranged | 2 (8.3) | 12 (7.5) | |
| iAMP21 | 1 (4.2) | 9 (5.6) | |
| Favorable | 4 (16.7) | 25 (15.5) | |
| Hyperdiploid | 2 (8.35) | 17 (10.5) | |
| t(12;21) | 2 (8.35) | 8 (5.0) | |
| Other/unknown | 16 (66.7) | 90 (55.9) | |
| Other | 8 (33.35) | 62 (38.5) | |
| Unknown | 8 (33.35) | 28 (17.4) | |
| MRD status by flow cytometry at EOI | |||
| Detected | 13 (54.2) | 77 (47.8) | .63 |
| Not detected | 8 (33.3) | 58 (36.0) | |
| Unknown | 3 (12.5) | 26 (16.2) | |
| Relapses pre–CAR T, median (range), n | 1 (0-5) | 1 (0-9) | .21 |
| Lines of therapy pre–CAR T, median (range), n | 3 (1-8) | 3 (1-10) | .13 |
| Prior CD19-directed therapy | 6 (25) | 32 (19.9) | .59 |
| Prior HSCT | 10 (41.7) | 37 (23.0) | .087 |
| Indication for CAR T | |||
| Second or greater relapse | 11 (45.8) | 76 (47.2) | .42 |
| Primary refractory | 6 (25.0) | 31 (19.3) | |
| Other | 7 (29.2) | 54 (33.5) | |
| Time from diagnosis to CAR T, median (range), mo | 31 (4-120) | 30 (2-164) | .42 |
| CAR+ viable T cells infused, median (range), ×106 cells per kg | 1.5 (0.24-5.1) | 1.7 (0.13-4.6) | .40 |
Unless otherwise noted, data are n (%).
CAR T, CAR T-cell therapy; EOI, end of induction; HSCT, hematopoietic stem cell transplant; MRD, minimal residual disease.