Patient and treatment characteristics
| Characteristic . | MRD-negative CR . | No response . | All patients . |
|---|---|---|---|
| Evaluable patients, n | 45 | 8 | 53 |
| Age, y | |||
| Median (IQR) | 39.0 (28.0-53.0) | 42.5 (30.5-54.5) | 39.0 (28.0-54.0) |
| Range | 20-76 | 22-66 | 20-76 |
| Sex, n (%) | |||
| Female | 23 (51) | 0 (0) | 23 (43) |
| Male | 22 (49) | 8 (100) | 30 (57) |
| ECOG PS, n (%) | |||
| 0 | 22 (49) | 4 (50) | 26 (49) |
| 1 | 22 (49) | 4 (50) | 26 (49) |
| 2 | 1 (2) | 0 (0) | 1 (2) |
| High-risk cytogenetics, n (%)* | |||
| t(9;22) BCR-ABL, Ph+ | 9 (20) | 2 (25) | 11 (21) |
| t(v;11) MLL rearrangement | 7 (13) | 0 (0) | 7 (13) |
| Low hypodiploidy (30-39 chromosomes) | 3 (6) | 0 (0) | 3 (6) |
| Near triploidy (60-78 chromosomes) | 2 (4) | 0 (0) | 2 (4) |
| iAMP21 | 0 (0) | 1 (13) | 1 (2) |
| Complex karyotype (≥5 abnormalities) | 14 (31) | 3 (38) | 17 (32) |
| Prior regimens, n | |||
| Median (IQR) | 3 (3-4) | 3.5 (2.5-6) | 3 (3-4) |
| Range | 1-11 | 1-7 | 1-11 |
| Prior allogeneic HCT, n (%) | |||
| Yes | 18 (40) | 5 (62) | 23 (43) |
| No | 27 (60) | 3 (38) | 30 (57) |
| Prior blinatumomab therapy, n (%) | |||
| Yes | 9 (20) | 1 (13) | 10 (19) |
| No | 36 (80) | 7 (87) | 43 (81) |
| Marrow disease burden by flow cytometry, % | |||
| Median (IQR) | 28 (0.65-74.7) | 22.9 (1.55-81.1) | 28 (1.10-79.0) |
| Range | 0.0-97.6 | 0.3-98.5 | 0.0-98.5 |
| ≥5% blasts with extramedullary disease, n (%) | 9 (20) | 4 (50) | 13 (25) |
| ≥5% blasts without extramedullary disease, n (%) | 20 (44) | 1 (13) | 21 (40) |
| <5% blasts with extramedullary disease, n (%) | 5 (11) | 0 (0) | 5 (9) |
| <5% blasts without extramedullary disease, n (%) | 11 (24) | 3 (37) | 14 (26) |
| Extramedullary disease, n (%) | |||
| Yes | 14 (31) | 4 (50) | 18 (34) |
| No | 31 (69) | 4 (50) | 35 (66) |
| CNS leukemic involvement, n (%) | |||
| Yes | 2 (4) | 3 (38) | 5 (9) |
| No | 43 (96) | 5 (62) | 48 (91) |
| Lymphodepletion, n (%) | |||
| Cyclophosphamide-based with fludarabine | 35 (78) | 7 (87) | 42 (79) |
| Cyclophosphamide-based without fludarabine | 10 (22) | 1 (13) | 11 (21) |
| Dose of CAR T cells per kg, n (%) | |||
| 2 × 105 cells | 26 (58) | 7 (87) | 33 (62) |
| 2 × 106 cells | 19 (42) | 1 (13) | 20 (38) |
| Characteristic . | MRD-negative CR . | No response . | All patients . |
|---|---|---|---|
| Evaluable patients, n | 45 | 8 | 53 |
| Age, y | |||
| Median (IQR) | 39.0 (28.0-53.0) | 42.5 (30.5-54.5) | 39.0 (28.0-54.0) |
| Range | 20-76 | 22-66 | 20-76 |
| Sex, n (%) | |||
| Female | 23 (51) | 0 (0) | 23 (43) |
| Male | 22 (49) | 8 (100) | 30 (57) |
| ECOG PS, n (%) | |||
| 0 | 22 (49) | 4 (50) | 26 (49) |
| 1 | 22 (49) | 4 (50) | 26 (49) |
| 2 | 1 (2) | 0 (0) | 1 (2) |
| High-risk cytogenetics, n (%)* | |||
| t(9;22) BCR-ABL, Ph+ | 9 (20) | 2 (25) | 11 (21) |
| t(v;11) MLL rearrangement | 7 (13) | 0 (0) | 7 (13) |
| Low hypodiploidy (30-39 chromosomes) | 3 (6) | 0 (0) | 3 (6) |
| Near triploidy (60-78 chromosomes) | 2 (4) | 0 (0) | 2 (4) |
| iAMP21 | 0 (0) | 1 (13) | 1 (2) |
| Complex karyotype (≥5 abnormalities) | 14 (31) | 3 (38) | 17 (32) |
| Prior regimens, n | |||
| Median (IQR) | 3 (3-4) | 3.5 (2.5-6) | 3 (3-4) |
| Range | 1-11 | 1-7 | 1-11 |
| Prior allogeneic HCT, n (%) | |||
| Yes | 18 (40) | 5 (62) | 23 (43) |
| No | 27 (60) | 3 (38) | 30 (57) |
| Prior blinatumomab therapy, n (%) | |||
| Yes | 9 (20) | 1 (13) | 10 (19) |
| No | 36 (80) | 7 (87) | 43 (81) |
| Marrow disease burden by flow cytometry, % | |||
| Median (IQR) | 28 (0.65-74.7) | 22.9 (1.55-81.1) | 28 (1.10-79.0) |
| Range | 0.0-97.6 | 0.3-98.5 | 0.0-98.5 |
| ≥5% blasts with extramedullary disease, n (%) | 9 (20) | 4 (50) | 13 (25) |
| ≥5% blasts without extramedullary disease, n (%) | 20 (44) | 1 (13) | 21 (40) |
| <5% blasts with extramedullary disease, n (%) | 5 (11) | 0 (0) | 5 (9) |
| <5% blasts without extramedullary disease, n (%) | 11 (24) | 3 (37) | 14 (26) |
| Extramedullary disease, n (%) | |||
| Yes | 14 (31) | 4 (50) | 18 (34) |
| No | 31 (69) | 4 (50) | 35 (66) |
| CNS leukemic involvement, n (%) | |||
| Yes | 2 (4) | 3 (38) | 5 (9) |
| No | 43 (96) | 5 (62) | 48 (91) |
| Lymphodepletion, n (%) | |||
| Cyclophosphamide-based with fludarabine | 35 (78) | 7 (87) | 42 (79) |
| Cyclophosphamide-based without fludarabine | 10 (22) | 1 (13) | 11 (21) |
| Dose of CAR T cells per kg, n (%) | |||
| 2 × 105 cells | 26 (58) | 7 (87) | 33 (62) |
| 2 × 106 cells | 19 (42) | 1 (13) | 20 (38) |
AUC28, area under the curve from day 0 to day 28; ECOG PS, Eastern Cooperative Oncology Group performance status; iAMP21, intrachromosomal amplification of a region of chromosome 21; IQR, interquartile range .
From cytogenetic analysis performed at any time after diagnosis; some patients had >1 abnormalities identified.