Characteristics of study subjects
| Characteristic . | Seropositive patients (n = 95) . | No CMV reactivation (n = 64) . | CMV reactivation (n = 31) . | P value∗ . | Clinically significant CMV (n = 10) . | P value† . |
|---|---|---|---|---|---|---|
| Age, median (IQR), y | 62 (53-69) | 62 (53-69) | 62 (55-69) | .506 | 67 (59-71) | .155 |
| Sex | .648 | .734 | ||||
| Male | 64 (67%) | 42 (66%) | 22 (71%) | 6 (60%) | ||
| Female | 31 (33%) | 22 (34%) | 9 (29%) | 4 (40%) | ||
| Hispanic or Latino | 62 (65%) | 38 (59%) | 24 (77%) | .109 | 8 (80%) | .301 |
| Race | .375 | .901 | ||||
| White | 84 (88%) | 58 (91%) | 26 (84%) | 9 (90%) | ||
| Black/African American | 10 (11%) | 5 (8%) | 5 (16%) | 1 (10%) | ||
| Asian | 1 (1%) | 1 (2%) | 0 | 0 | ||
| CAR T-cell product | .83 | .518 | ||||
| Axicabtagene ciloleucel (Yescarta) | 67 (71%) | 47 (73%) | 20 (65%) | 5 (50%) | ||
| Brexucabtagene autoleucel (Tecartus) | 15 (16%) | 9 (14%) | 6 (19%) | 3 (30%) | ||
| Tisagenlecleucel (Kymriah) | 7 (7%) | 5 (8%) | 2 (7%) | 1 (10%) | ||
| Idecabtagene vicleucel (ABECMA) | 4 (4%) | 2 (3%) | 2 (7%) | 1 (10%) | ||
| Lisocabtagene maraleucel (Breyanzi) | 2 (2%) | 1 (2%) | 1 (3%) | 0 | ||
| Conditioning regimen | >.999 | >.999 | ||||
| Fludarabine/cytoxan | 94 (99%) | 63 (98%) | 31 (100%) | 10 (100%) | ||
| Bendamustine | 1 (1%) | 1 (2%) | 0 | 0 | ||
| Main diagnosis | .75 | .513 | ||||
| Non-Hodgkin lymphoma | 88 (93%) | 60 (94%) | 28 (90%) | 9 (90%) | ||
| Multiple myeloma | 4 (4%) | 2 (3%) | 2 (7%) | 1 (10%) | ||
| Leukemia | 3 (3%) | 2 (3%) | 1 (3%) | 0 | ||
| Karnofsky performance status, median (IQR) | 70 (70-80) | 70 (70-80) | 70 (60-80) | .172 | 70 (50-80) | .06 |
| Prior transplant | .023 | .264 | ||||
| Yes | 23 (24%) | 20 (31%) | 3 (10%) | 1 (10%) | ||
| No | 72 (76%) | 44 (69%) | 28 (90%) | 9 (90%) | ||
| Neutropenic during admission | .169 | >.999 | ||||
| Yes | 90 (95%) | 59 (92%) | 31 (100%) | 10 (100%) | ||
| No | 5 (5%) | 5 (8%) | 0 | 0 | ||
| ANC at day 30‡ | 1.07 (0.47-1.75) | 1.18 (0.52-1.8) | 0.83 (0.45-1.71) | .4 | 0.9 (0.24-3.14) | .822 |
| Initial CMV viremia (IQR) | - | - | 137 (137-137) | n/a | 173 (137-1424) | n/a |
| Peak CMV viremia (IQR) | - | - | 137 (137-1217) | n/a | 2388 (1091-6841) | n/a |
| CRS any grade§ | 73 (78%) | 48 (75%) | 25 (83%) | .435 | 9 (100%) | .192 |
| CRS onset after CAR T-cell infusion, d (IQR)§ | 4 (2-6) | 4 (2-7) | 5 (2-6) | .795 | 5 (1.5-5.5) | .757 |
| CRS grade ≥ 2§ | 25 (27%) | 17 (27%) | 8 (27%) | .999 | 3 (33%) | .698 |
| CRS grade ≥ 3§ | 6 (6%) | 2 (3%) | 4 (13%) | .08 | 1 (11%) | .33 |
| Tocilizumab§ | 65 (69%) | 42 (66%) | 23 (77%) | .343 | 9 (100%) | .05 |
| Corticosteroids§ | 51 (54%) | 31 (48%) | 20 (67%) | .122 | 9 (100%) | .003 |
| Anakinra§ | 9 (10%) | 4 (6%) | 5 (17%) | .139 | 3 (33%) | .036 |
| Hypogammaglobulinemia‖ | .433 | .435 | ||||
| Yes | 26 (43%) | 18 (47%) | 8 (36%) | 2 (25%) | ||
| No | 34 (57%) | 20 (53%) | 14 (64%) | 6 (75%) | ||
| Relapsed/progressive disease | .376 | .299 | ||||
| Yes | 39 (41%) | 24 (37.5%) | 15 (48%) | 6 (60%) | ||
| No | 56 (59%) | 40 (62.5%) | 16 (52%) | 4 (40%) | ||
| ICANS max grade§ | .145 | .003 | ||||
| 0 | 53 (56%) | 40 (63%) | 13 (43%) | 1 (11%) | ||
| 1 | 11 (12%) | 7 (11%) | 4 (13%) | 1 (11%) | ||
| 2 | 8 (9%) | 3 (5%) | 5 (17%) | 2 (22%) | ||
| 3 | 19 (20%) | 13 (20%) | 6 (20%) | 3 (33%) | ||
| 4 | 3 (3%) | 1 (2%) | 2 (7%) | 2 (22%) | ||
| No. of previous lines of therapy | .48 | .345 | ||||
| 1 | 10 (11%) | 7 (11%) | 3 (10%) | 0 | ||
| 2 | 14 (15%) | 12 (19%) | 2 (6%) | 0 | ||
| 3 | 32 (34%) | 19 (30%) | 13 (42%) | 5 (50%) | ||
| 4 | 24 (25%) | 15 (23%) | 9 (29%) | 4 (40%) | ||
| ≥5 | 15 (16%) | 11 (17%) | 4 (13%) | 1 (10%) |
| Characteristic . | Seropositive patients (n = 95) . | No CMV reactivation (n = 64) . | CMV reactivation (n = 31) . | P value∗ . | Clinically significant CMV (n = 10) . | P value† . |
|---|---|---|---|---|---|---|
| Age, median (IQR), y | 62 (53-69) | 62 (53-69) | 62 (55-69) | .506 | 67 (59-71) | .155 |
| Sex | .648 | .734 | ||||
| Male | 64 (67%) | 42 (66%) | 22 (71%) | 6 (60%) | ||
| Female | 31 (33%) | 22 (34%) | 9 (29%) | 4 (40%) | ||
| Hispanic or Latino | 62 (65%) | 38 (59%) | 24 (77%) | .109 | 8 (80%) | .301 |
| Race | .375 | .901 | ||||
| White | 84 (88%) | 58 (91%) | 26 (84%) | 9 (90%) | ||
| Black/African American | 10 (11%) | 5 (8%) | 5 (16%) | 1 (10%) | ||
| Asian | 1 (1%) | 1 (2%) | 0 | 0 | ||
| CAR T-cell product | .83 | .518 | ||||
| Axicabtagene ciloleucel (Yescarta) | 67 (71%) | 47 (73%) | 20 (65%) | 5 (50%) | ||
| Brexucabtagene autoleucel (Tecartus) | 15 (16%) | 9 (14%) | 6 (19%) | 3 (30%) | ||
| Tisagenlecleucel (Kymriah) | 7 (7%) | 5 (8%) | 2 (7%) | 1 (10%) | ||
| Idecabtagene vicleucel (ABECMA) | 4 (4%) | 2 (3%) | 2 (7%) | 1 (10%) | ||
| Lisocabtagene maraleucel (Breyanzi) | 2 (2%) | 1 (2%) | 1 (3%) | 0 | ||
| Conditioning regimen | >.999 | >.999 | ||||
| Fludarabine/cytoxan | 94 (99%) | 63 (98%) | 31 (100%) | 10 (100%) | ||
| Bendamustine | 1 (1%) | 1 (2%) | 0 | 0 | ||
| Main diagnosis | .75 | .513 | ||||
| Non-Hodgkin lymphoma | 88 (93%) | 60 (94%) | 28 (90%) | 9 (90%) | ||
| Multiple myeloma | 4 (4%) | 2 (3%) | 2 (7%) | 1 (10%) | ||
| Leukemia | 3 (3%) | 2 (3%) | 1 (3%) | 0 | ||
| Karnofsky performance status, median (IQR) | 70 (70-80) | 70 (70-80) | 70 (60-80) | .172 | 70 (50-80) | .06 |
| Prior transplant | .023 | .264 | ||||
| Yes | 23 (24%) | 20 (31%) | 3 (10%) | 1 (10%) | ||
| No | 72 (76%) | 44 (69%) | 28 (90%) | 9 (90%) | ||
| Neutropenic during admission | .169 | >.999 | ||||
| Yes | 90 (95%) | 59 (92%) | 31 (100%) | 10 (100%) | ||
| No | 5 (5%) | 5 (8%) | 0 | 0 | ||
| ANC at day 30‡ | 1.07 (0.47-1.75) | 1.18 (0.52-1.8) | 0.83 (0.45-1.71) | .4 | 0.9 (0.24-3.14) | .822 |
| Initial CMV viremia (IQR) | - | - | 137 (137-137) | n/a | 173 (137-1424) | n/a |
| Peak CMV viremia (IQR) | - | - | 137 (137-1217) | n/a | 2388 (1091-6841) | n/a |
| CRS any grade§ | 73 (78%) | 48 (75%) | 25 (83%) | .435 | 9 (100%) | .192 |
| CRS onset after CAR T-cell infusion, d (IQR)§ | 4 (2-6) | 4 (2-7) | 5 (2-6) | .795 | 5 (1.5-5.5) | .757 |
| CRS grade ≥ 2§ | 25 (27%) | 17 (27%) | 8 (27%) | .999 | 3 (33%) | .698 |
| CRS grade ≥ 3§ | 6 (6%) | 2 (3%) | 4 (13%) | .08 | 1 (11%) | .33 |
| Tocilizumab§ | 65 (69%) | 42 (66%) | 23 (77%) | .343 | 9 (100%) | .05 |
| Corticosteroids§ | 51 (54%) | 31 (48%) | 20 (67%) | .122 | 9 (100%) | .003 |
| Anakinra§ | 9 (10%) | 4 (6%) | 5 (17%) | .139 | 3 (33%) | .036 |
| Hypogammaglobulinemia‖ | .433 | .435 | ||||
| Yes | 26 (43%) | 18 (47%) | 8 (36%) | 2 (25%) | ||
| No | 34 (57%) | 20 (53%) | 14 (64%) | 6 (75%) | ||
| Relapsed/progressive disease | .376 | .299 | ||||
| Yes | 39 (41%) | 24 (37.5%) | 15 (48%) | 6 (60%) | ||
| No | 56 (59%) | 40 (62.5%) | 16 (52%) | 4 (40%) | ||
| ICANS max grade§ | .145 | .003 | ||||
| 0 | 53 (56%) | 40 (63%) | 13 (43%) | 1 (11%) | ||
| 1 | 11 (12%) | 7 (11%) | 4 (13%) | 1 (11%) | ||
| 2 | 8 (9%) | 3 (5%) | 5 (17%) | 2 (22%) | ||
| 3 | 19 (20%) | 13 (20%) | 6 (20%) | 3 (33%) | ||
| 4 | 3 (3%) | 1 (2%) | 2 (7%) | 2 (22%) | ||
| No. of previous lines of therapy | .48 | .345 | ||||
| 1 | 10 (11%) | 7 (11%) | 3 (10%) | 0 | ||
| 2 | 14 (15%) | 12 (19%) | 2 (6%) | 0 | ||
| 3 | 32 (34%) | 19 (30%) | 13 (42%) | 5 (50%) | ||
| 4 | 24 (25%) | 15 (23%) | 9 (29%) | 4 (40%) | ||
| ≥5 | 15 (16%) | 11 (17%) | 4 (13%) | 1 (10%) |
Data are presented as absolute numbers (percentages), unless specified otherwise.
“n/a” indicates instances where P values could not be calculated for initial and peak CMV viremia, because no comparison is indicated.
ANC, absolute neutrophil count; IgG, Immunoglobulin G.
Bolded text indicates statistical significance
P value for comparison between the CMV reactivation and no CMV reactivation groups using Mann-Whitney U or Fisher exact test.
P value for comparison between the clinically significant CMV and no CMV reactivation groups using Mann-Whitney U or Fisher exact test.
For ANC levels on day 30, 2 patients are missing values from both the no CMV reactivation group and the CMV reactivation group.
One patient who had clinically significant CMV was excluded because the patient reactivated before immunosuppression.
Hypogammaglobulinemia was defined as IgG <400 mg/dL. In the no CMV reactivation group, 26 patients are missing IgG levels; in the CMV reactivation group, 9 patients are missing IgG levels; and in the clinically significant CMV group, 2 patients are missing IgG levels.