Patient, disease, and treatment characteristics of all (n = 420) and relapsed (n = 163) patients
| . | All (n = 420) . | Relapsed (n = 163∗) . |
|---|---|---|
| Demographics | ||
| Female, n (%) | 156 (37.1) | 71 (37.1) |
| Median age at B-ALL diagnosis, y (IQR) | 7.6 (3.4-13.8) | 7.3 (0.02-24.3) |
| Median age at CAR infusion, y (IQR) | 12.7 (7.1-17.5) | 11.8 (0.8-30.4) |
| Race (%) | ||
| White | 275 (65.5) | 108 (66.2) |
| Black | 17 (4.0) | 5 (3.1) |
| Asian | 20 (4.8) | 8 (4.9) |
| Other (mixed)/unknown | 108 (25.7) | 38 (23.3) |
| Ethnicity (%) | ||
| Non-Hispanic | 255 (60.7) | 109 (66.9) |
| Hispanic | 134 (31.9) | 42 (25.8) |
| Unknown | 31 (7.4) | 12 (7.4) |
| Prior therapy (prior to CAR T cells) | ||
| Primary refractory disease, n (%) | 92 (21.9) | 29 (17.8) |
| No. of prior CR, median (range) | 2 (0-7) | 2 (0-7) |
| Prior blinatumomab, n (%) | 33 (7.9) | 35 (21.5) |
| Prior HSCT, n (%) | 159 (37.9) | 76 (46.6) |
| Cytogenetics (%) | ||
| Normal | 41 (9.8) | 18 (11) |
| ETV6-RUNX1 | 24 (5.7) | 16 (9.8) |
| KMT2Ar | 38 (9) | 15 (9.2) |
| Ph+/Ph-like | 61 (14.5) | 17 (10.4) |
| Hypodiploid | 12 (2.9) | 7 (4.3) |
| Disease status pre-CAR (%) | ||
| M1 or MRD-negative marrow | 217 (51.7) | 64 (39.3) |
| M2/M3 marrow | 203 (48.3) | 99 (60.7) |
| CNS3 | 4 (0.9) | 1 (0.01) |
| Active EM disease | 22 (5.2) | 9 (5.5) |
| Active PB blasts | 56 (13.3) | 30 (18.4) |
| CAR T-cell construct infused (%)† | ||
| CD19/4-1BB | 277 (66.0) | 115 (70.6) |
| Tisagenlecleucel (Kymriah) | 88 (21.0) | 34 (20.9) |
| CD19/28z | 55 (13.1) | 14 (8.6) |
| Relapse phenotype (%) | ||
| CD19pos | N/A | 83 (50.9) |
| CD19neg | N/A | 68 (41.7) |
| Lineage switch | N/A | 12 (7.4) |
| . | All (n = 420) . | Relapsed (n = 163∗) . |
|---|---|---|
| Demographics | ||
| Female, n (%) | 156 (37.1) | 71 (37.1) |
| Median age at B-ALL diagnosis, y (IQR) | 7.6 (3.4-13.8) | 7.3 (0.02-24.3) |
| Median age at CAR infusion, y (IQR) | 12.7 (7.1-17.5) | 11.8 (0.8-30.4) |
| Race (%) | ||
| White | 275 (65.5) | 108 (66.2) |
| Black | 17 (4.0) | 5 (3.1) |
| Asian | 20 (4.8) | 8 (4.9) |
| Other (mixed)/unknown | 108 (25.7) | 38 (23.3) |
| Ethnicity (%) | ||
| Non-Hispanic | 255 (60.7) | 109 (66.9) |
| Hispanic | 134 (31.9) | 42 (25.8) |
| Unknown | 31 (7.4) | 12 (7.4) |
| Prior therapy (prior to CAR T cells) | ||
| Primary refractory disease, n (%) | 92 (21.9) | 29 (17.8) |
| No. of prior CR, median (range) | 2 (0-7) | 2 (0-7) |
| Prior blinatumomab, n (%) | 33 (7.9) | 35 (21.5) |
| Prior HSCT, n (%) | 159 (37.9) | 76 (46.6) |
| Cytogenetics (%) | ||
| Normal | 41 (9.8) | 18 (11) |
| ETV6-RUNX1 | 24 (5.7) | 16 (9.8) |
| KMT2Ar | 38 (9) | 15 (9.2) |
| Ph+/Ph-like | 61 (14.5) | 17 (10.4) |
| Hypodiploid | 12 (2.9) | 7 (4.3) |
| Disease status pre-CAR (%) | ||
| M1 or MRD-negative marrow | 217 (51.7) | 64 (39.3) |
| M2/M3 marrow | 203 (48.3) | 99 (60.7) |
| CNS3 | 4 (0.9) | 1 (0.01) |
| Active EM disease | 22 (5.2) | 9 (5.5) |
| Active PB blasts | 56 (13.3) | 30 (18.4) |
| CAR T-cell construct infused (%)† | ||
| CD19/4-1BB | 277 (66.0) | 115 (70.6) |
| Tisagenlecleucel (Kymriah) | 88 (21.0) | 34 (20.9) |
| CD19/28z | 55 (13.1) | 14 (8.6) |
| Relapse phenotype (%) | ||
| CD19pos | N/A | 83 (50.9) |
| CD19neg | N/A | 68 (41.7) |
| Lineage switch | N/A | 12 (7.4) |
Blina, blinatumomab; EM, extramedullary; KMT2Ar, KMT2A-rearranged; MRD, minimal residual disease (defined as <.01% bone marrow blasts by multiparameter flow cytometry); N/A, not applicable; PB, peripheral blood.
A total of 166 patients experienced relapse, but immunophenotype at relapse was only available in 163 patients, which constituted the analysis cohort.
4-1BB CAR T-cell constructs were comprised of 1 of 2 available constructs, including the construct that eventually was FDA approved; tisagenlecleucel refers to the commercially available construct.