Patient transplantation outcomes
| Characteristics . | All CTL-infused patients (n=50) . | Cohorts used for comparative analysis . | P* . | |
|---|---|---|---|---|
| CTL (n = 54) . | Control (n = 128) . | |||
| Median length of follow-up, months (range) | 26 (2-80) | 26 (2-80) | 25 (1-98) | .79 |
| Number of patients treated with CTL | 50 | 45 | — | |
| Median day of infusion | 45 (29-115) | 45 (29-115) | — | |
| No. of days posttransplant (range) | ||||
| CMV reactivation | ||||
| Total | 26 (52) | 25 (46) | 77 (60) | .17 |
| Preinfusion | 14 (28) | 9 (2) | — | |
| Day of infusion | 7 (14) | 4 (8) | — | |
| Postinfusion | 5 (10) | 6 (11) | — | |
| CMV in uninfused patients | — | 6 (11) | 77 (60) | |
| Peak titer (median) | Positive below linear limit of assay | 0 | 600 | .04 |
| IV treatment | 9 (18) | 9 (17) | 46 (36) | .01 |
| Days of IV treatment (days per patient in cohort) | 4.08 | 3.4 | 8.9 | .03 |
| CMV disease | 1 (2) | 3 (6) | 11 (9) | .76 |
| Death from CMV disease | 1 (2) | 1 (2) | 1 (1) | .51 |
| aGVHD | ||||
| 2-4 | 12 (24)† | 13 (24) | 24 (18) | .42 |
| 3-4 | 4 (8)‡ | 4 (7) | 9 (7) | 1.0 |
| cGVHD | 21 (42) | 23 (45) | 68 (57) | .15 |
| Limited | 3 | 5 | 17 | |
| Extensive | 17 | 18 | 49 | |
| Not recorded | 1 | 2 | ||
| Mortality day 1-100 | 3 (6) | 3 (6) | 9 (7) | 1.0 |
| Relapse | 13 (26) | 11 (20) | 23 (18) | .70 |
| Death | ||||
| Total | 15 (30) | 18 (33) | 37 (29) | .55 |
| Relapse/progressive disease | 6 (12) | 6 (11) | 13 (10) | |
| aGVHD | 2 (4) | 1 (2) | 1 (1) | |
| cGVHD | — | — | 3 (2) | |
| Infection | 2 (4) | 4 (7) | 10 (8) | |
| Graft failure | 1 (2) | 1 (2) | — | |
| TTP | 1 (2) | — | — | |
| Second malignancy | 2 (4) | 2 (4) | — | |
| Other | 1§ (2) | 4‖ (7) | 10¶ (9) | |
| Characteristics . | All CTL-infused patients (n=50) . | Cohorts used for comparative analysis . | P* . | |
|---|---|---|---|---|
| CTL (n = 54) . | Control (n = 128) . | |||
| Median length of follow-up, months (range) | 26 (2-80) | 26 (2-80) | 25 (1-98) | .79 |
| Number of patients treated with CTL | 50 | 45 | — | |
| Median day of infusion | 45 (29-115) | 45 (29-115) | — | |
| No. of days posttransplant (range) | ||||
| CMV reactivation | ||||
| Total | 26 (52) | 25 (46) | 77 (60) | .17 |
| Preinfusion | 14 (28) | 9 (2) | — | |
| Day of infusion | 7 (14) | 4 (8) | — | |
| Postinfusion | 5 (10) | 6 (11) | — | |
| CMV in uninfused patients | — | 6 (11) | 77 (60) | |
| Peak titer (median) | Positive below linear limit of assay | 0 | 600 | .04 |
| IV treatment | 9 (18) | 9 (17) | 46 (36) | .01 |
| Days of IV treatment (days per patient in cohort) | 4.08 | 3.4 | 8.9 | .03 |
| CMV disease | 1 (2) | 3 (6) | 11 (9) | .76 |
| Death from CMV disease | 1 (2) | 1 (2) | 1 (1) | .51 |
| aGVHD | ||||
| 2-4 | 12 (24)† | 13 (24) | 24 (18) | .42 |
| 3-4 | 4 (8)‡ | 4 (7) | 9 (7) | 1.0 |
| cGVHD | 21 (42) | 23 (45) | 68 (57) | .15 |
| Limited | 3 | 5 | 17 | |
| Extensive | 17 | 18 | 49 | |
| Not recorded | 1 | 2 | ||
| Mortality day 1-100 | 3 (6) | 3 (6) | 9 (7) | 1.0 |
| Relapse | 13 (26) | 11 (20) | 23 (18) | .70 |
| Death | ||||
| Total | 15 (30) | 18 (33) | 37 (29) | .55 |
| Relapse/progressive disease | 6 (12) | 6 (11) | 13 (10) | |
| aGVHD | 2 (4) | 1 (2) | 1 (1) | |
| cGVHD | — | — | 3 (2) | |
| Infection | 2 (4) | 4 (7) | 10 (8) | |
| Graft failure | 1 (2) | 1 (2) | — | |
| TTP | 1 (2) | — | — | |
| Second malignancy | 2 (4) | 2 (4) | — | |
| Other | 1§ (2) | 4‖ (7) | 10¶ (9) | |
The table presents characteristics of all 50 patients who received CTL infusion (column: All CTL-infused patients); patients for whom a CTL product was available and who fulfilled criteria for comparative analysis at day 28, including 45 patients who received CTL and 9 who did not receive infusions for clinical reasons (column: CTL); and control patients who fulfilled eligibility criteria for the trial and for the comparative analysis but who did not have a CTL product made (column: Control) (See text for inclusion and exclusion criteria for comparative analysis of CTL trial recruits and controls). Values are numbers (percentages) unless otherwise indicated. Abbreviations are explained in Table 1.
P values refer to comparisons between columns 3 and 4; all are 2-sided; and values < .05 are considered significant.
Altogether 7 of 12 cases developed post-CTL infusion.
Altogether 2 of 4 cases developed post-CTL infusion
Pulmonary hypertension.
One case of pulmonary hypertension and 3 cases of organ failure (not specified).
Two cases of hemorrhage, 1 case of hepatic failure, 5 cases of organ failure (not specified), and 2 cases in which the cause was not recorded.