Characteristics of patients receiving CD19 CAR T-cell immunotherapy with concurrent ibrutinib (N = 19)
| Characteristic . | Data . |
|---|---|
| Age, y | |
| Median, IQR | 65 (56-69) |
| Range | 40-71 |
| Sex | |
| Female | 7 (37) |
| Male | 12 (63) |
| ECOG score | |
| 0 | 10 (53) |
| 1 | 9 (47) |
| History of Richter’s transformation | 4 (21) |
| High-risk cytogenetics* | 17 (89) |
| 17p deletion | 14 (74) |
| Complex karyotype† | 14 (74) |
| Cross-sectional tumor area, mm2‡ | |
| Median (IQR) | 1538 (840-3958) |
| Range | 0-9097 |
| Bulky disease (largest node ≥ 5 cm) | 4 (21) |
| Maximum SUV | |
| Median (IQR) | 4.4 (3.4-7.0) |
| Range | 0.0-24.0 |
| Serum LDH concentration (U/L) | |
| Median (IQR) | 155 (135-206) |
| Range | 90-387 |
| Absolute lymphocyte count – blood (109cells/L) | |
| Median (IQR) | 1.12 (0.84-3.95) |
| Range | 0.20-59.00 |
| Absolute CLL cell count – blood (109cells/L) | |
| Median (IQR) | 0.45 (0.13-3.13) |
| Range | 0.01-54.00 |
| Marrow CLL burden | |
| Immunohistochemistry (bone marrow biopsy, % cellularity) | |
| Median (IQR) | 35 (9-70) |
| Range | 0-90 |
| Flow cytometry (bone marrow aspirate, % of leukocytes) | |
| Median (IQR) | 26 (12-60) |
| Range | 2-90 |
| Prior therapies | |
| Median (IQR) | 5 (4-7) |
| Range | 1-10 |
| Prior allogeneic stem cell transplantation | 3 (16) |
| Prior intolerance to ibrutinib | 2 (10) |
| Duration of last treatment with ibrutinib, d§ | |
| Median (IQR) | 105 (26-741) |
| Range | 14-2185 |
| Prior idelalisib treatment | 4 (21) |
| Prior venetoclax treatment | 11 (58)¶ |
| Characteristic . | Data . |
|---|---|
| Age, y | |
| Median, IQR | 65 (56-69) |
| Range | 40-71 |
| Sex | |
| Female | 7 (37) |
| Male | 12 (63) |
| ECOG score | |
| 0 | 10 (53) |
| 1 | 9 (47) |
| History of Richter’s transformation | 4 (21) |
| High-risk cytogenetics* | 17 (89) |
| 17p deletion | 14 (74) |
| Complex karyotype† | 14 (74) |
| Cross-sectional tumor area, mm2‡ | |
| Median (IQR) | 1538 (840-3958) |
| Range | 0-9097 |
| Bulky disease (largest node ≥ 5 cm) | 4 (21) |
| Maximum SUV | |
| Median (IQR) | 4.4 (3.4-7.0) |
| Range | 0.0-24.0 |
| Serum LDH concentration (U/L) | |
| Median (IQR) | 155 (135-206) |
| Range | 90-387 |
| Absolute lymphocyte count – blood (109cells/L) | |
| Median (IQR) | 1.12 (0.84-3.95) |
| Range | 0.20-59.00 |
| Absolute CLL cell count – blood (109cells/L) | |
| Median (IQR) | 0.45 (0.13-3.13) |
| Range | 0.01-54.00 |
| Marrow CLL burden | |
| Immunohistochemistry (bone marrow biopsy, % cellularity) | |
| Median (IQR) | 35 (9-70) |
| Range | 0-90 |
| Flow cytometry (bone marrow aspirate, % of leukocytes) | |
| Median (IQR) | 26 (12-60) |
| Range | 2-90 |
| Prior therapies | |
| Median (IQR) | 5 (4-7) |
| Range | 1-10 |
| Prior allogeneic stem cell transplantation | 3 (16) |
| Prior intolerance to ibrutinib | 2 (10) |
| Duration of last treatment with ibrutinib, d§ | |
| Median (IQR) | 105 (26-741) |
| Range | 14-2185 |
| Prior idelalisib treatment | 4 (21) |
| Prior venetoclax treatment | 11 (58)¶ |
Unless otherwise noted, data are n (%). All variables were assessed prior to lymphodepletion chemotherapy, unless specified.
ECOG, Eastern Cooperative Oncology Group; IQR, interquartile range; LDH, lactate dehydrogenase; SUV, standardized uptake value.
Defined as 17p deletion and/or complex karyotype.
Defined as ≥3 chromosomal abnormalities.
In patients with evaluable nodal disease (n = 16); sum of the product of the diameters of up to 6 of the largest lymph nodes or masses evaluated on the prelymphodepletion CT scan.
Duration of the last continuous ibrutinib therapy before leukapheresis.
Six of 11 patients had progressed on venetoclax.