Characteristics of participants
| Characteristics . | All CTL infused patients (n = 50) . | Cohorts used for comparative analysis . | P* . | |
|---|---|---|---|---|
| CTL (n = 54) . | Control (n = 128) . | |||
| Age (median, range) | 48 (4-68) | 48 (4-68) | 46 (5-69) | .73 |
| Sex (M:F) (%) | 58:42 | 54:46 | 60:40 | .42 |
| Indication for transplant | ||||
| AML | 30 (60) | 31 (57) | 64 (50) | .52 |
| ALL | 7 (14) | 8 (14) | 24 (19) | |
| CML | — | — | 5 (4) | |
| MDS | 2 (4) | 3 (6) | 4 (3) | |
| NHL | 5 (10) | 6 (11) | 15 (12) | |
| HD | 1 (2) | — | 1 (1) | |
| MM | 2 (4) | 2 (4) | 3 (2) | |
| Other | 3 (6) | 4 (7) | 12 (9) | |
| Stage of disease | ||||
| CR1 | 18 (36) | 19 (35) | 50 (39) | .72 |
| >CR1 | 24 (48) | 25 (46) | 50 (39) | |
| N/A or unknown | 8 (16) | 10 (19) | 28 (22) | |
| CMV serostatus (recipient) | .38 | |||
| Positive | 36 (72) | 38 (70) | 98 (77) | |
| Negative | 14 (28) | 16 (30) | 30 (23) | |
| Donor | ||||
| Sib | 36 (72) | 40 (74) | 85 (66) | .57 |
| MUD | 14 (28) | 14 (26) | 41 (32) | |
| Matched other family | — | — | 2 (2) | |
| HLA matching | ||||
| 6/6 | 45 (90) | 49 (91) | 126 (98) | .03 |
| 5/6 | 5 (10) | 5 (9) | 2 (2) | |
| Stem-cell source | ||||
| Bone marrow | 8 (16) | 8 (15) | 18 (14) | .90 |
| PBSC | 42 (84) | 46 (85) | 110 (86) | |
| Conditioning | ||||
| Busulphan/Cyclophosphamide | 8 (16) | 11 (20) | 32 (25) | .13 |
| Cyclophosphamide/TBI | 8 (16) | 10 (19) | 37 (29) | |
| Fludarabine/Melphalan/BCNU | 11 (22) | 11 (20) | 18 (14) | |
| Fludarabine/Melphalan | 12 (24) | 10 (19) | 8 (6) | |
| Fludarabine/Busulphan | 2 (4) | 2 (4) | 7 (6) | |
| Fludarabine/Cyclophosphamide | 4 (8) | 4 (7) | 16 (13) | |
| Other/None | 5 (10) | 6 (11) | 10 (8) | |
| T-cell depletion | 26 (52) | 26 (48) | 53 (41) | .41 |
| Antithymocyte globulin | 22 | 23 | 46 | |
| Alemtuzumab | 3 | 2 | 4 | |
| CD34+ selection | 1 | 1 | 3 | |
| Characteristics . | All CTL infused patients (n = 50) . | Cohorts used for comparative analysis . | P* . | |
|---|---|---|---|---|
| CTL (n = 54) . | Control (n = 128) . | |||
| Age (median, range) | 48 (4-68) | 48 (4-68) | 46 (5-69) | .73 |
| Sex (M:F) (%) | 58:42 | 54:46 | 60:40 | .42 |
| Indication for transplant | ||||
| AML | 30 (60) | 31 (57) | 64 (50) | .52 |
| ALL | 7 (14) | 8 (14) | 24 (19) | |
| CML | — | — | 5 (4) | |
| MDS | 2 (4) | 3 (6) | 4 (3) | |
| NHL | 5 (10) | 6 (11) | 15 (12) | |
| HD | 1 (2) | — | 1 (1) | |
| MM | 2 (4) | 2 (4) | 3 (2) | |
| Other | 3 (6) | 4 (7) | 12 (9) | |
| Stage of disease | ||||
| CR1 | 18 (36) | 19 (35) | 50 (39) | .72 |
| >CR1 | 24 (48) | 25 (46) | 50 (39) | |
| N/A or unknown | 8 (16) | 10 (19) | 28 (22) | |
| CMV serostatus (recipient) | .38 | |||
| Positive | 36 (72) | 38 (70) | 98 (77) | |
| Negative | 14 (28) | 16 (30) | 30 (23) | |
| Donor | ||||
| Sib | 36 (72) | 40 (74) | 85 (66) | .57 |
| MUD | 14 (28) | 14 (26) | 41 (32) | |
| Matched other family | — | — | 2 (2) | |
| HLA matching | ||||
| 6/6 | 45 (90) | 49 (91) | 126 (98) | .03 |
| 5/6 | 5 (10) | 5 (9) | 2 (2) | |
| Stem-cell source | ||||
| Bone marrow | 8 (16) | 8 (15) | 18 (14) | .90 |
| PBSC | 42 (84) | 46 (85) | 110 (86) | |
| Conditioning | ||||
| Busulphan/Cyclophosphamide | 8 (16) | 11 (20) | 32 (25) | .13 |
| Cyclophosphamide/TBI | 8 (16) | 10 (19) | 37 (29) | |
| Fludarabine/Melphalan/BCNU | 11 (22) | 11 (20) | 18 (14) | |
| Fludarabine/Melphalan | 12 (24) | 10 (19) | 8 (6) | |
| Fludarabine/Busulphan | 2 (4) | 2 (4) | 7 (6) | |
| Fludarabine/Cyclophosphamide | 4 (8) | 4 (7) | 16 (13) | |
| Other/None | 5 (10) | 6 (11) | 10 (8) | |
| T-cell depletion | 26 (52) | 26 (48) | 53 (41) | .41 |
| Antithymocyte globulin | 22 | 23 | 46 | |
| Alemtuzumab | 3 | 2 | 4 | |
| CD34+ selection | 1 | 1 | 3 | |
The table presents characteristics for 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. Percentages may not add to 100% due to rounding. CR1, first complete remission.