Patient, disease, and transplantation-related characteristics
| . | ATG . | Alemtuzumab . | T cell–replete . | P . |
|---|---|---|---|---|
| No. of patients | 191 | 132 | 392 | |
| Age at transplantation, y | ||||
| Median (range) | 10 (1-18) | 9 (< 1-18) | 10 (< 1-18) | .10 |
| 1-5, n (%) | 18 (9) | 19 (14) | 65 (17) | |
| 6-10, n (%) | 78 (41) | 58 (44) | 141 (36) | |
| 11-18, n (%) | 95 (50) | 55 (42) | 186 (47) | |
| Male sex, n (%) | 128 (67) | 74 (56) | 247 (63) | .13 |
| FAB subtype, n (%) | ||||
| Pre-B | 144 (75) | 115 (87) | 336 (86) | .001 |
| B cell | 3 ( 2) | 1 ( 1) | 6 ( 2) | |
| T cell | 36 (19) | 13 (10) | 32 ( 8) | |
| Not reported | 8 ( 4) | 3 ( 2) | 18 ( 5) | |
| Cytogenetic risk group, n (%)* | ||||
| Standard-risk | 111(58) | 81 (62) | 209 (53) | |
| Poor-risk | 33 (17) | 37 (28) | 72 (18) | |
| Not reported | 47 (25) | 14 (11) | 111 (28) | |
| Disease status at transplantation, n (%) | ||||
| 1st CR | 53 (28) | 31 (23) | 91 (23) | .67 |
| 2nd CR | 87 (46) | 72 (55) | 200 (51) | |
| 3rd and beyond CR | 34 (18) | 22 (17) | 68 (17) | |
| Primary induction failure/relapse | 17 (9) | 7 (5) | 33 (8) | |
| Conditioning regimen, n (%) | ||||
| TBI + cyclophosphamide + other agents† | 70 (37) | 3 (2) | 54 (14) | < .001 |
| TBI + cyclophosphamide‡ | 85 (45) | 122 (92) | 311 (79) | |
| TBI + other agents§ | 36 (19) | 7 (5) | 27 (7) | |
| TBI dose, cGy, n (%) | ||||
| 1000 | 4 ( 2) | 31 ( 7) | < .001 | |
| 1200 | 162 (85) | 17 (13) | 155 (40) | |
| 1320 | 11 ( 6) | 90 (23) | ||
| 1400 | 13 ( 7) | 44 (33) | 93 (24) | |
| 1440 | 1 (< 1) | 71 (54) | 23 ( 6) | |
| Graft type, n (%) | ||||
| BM | 148 (77) | 111 (84) | 329 (84) | .13 |
| Peripheral blood | 43 (23) | 21 (16) | 63 (16) | |
| GVHD prophylaxis, n (%) | ||||
| Tacrolimus-containing regimen | 36 (19) | 53 (40) | 103 (27) | < .001 |
| Cyclosporine-containing regimen | 155 (81) | 79 (60) | 289 (73) | |
| Donor-recipient HLA match, n (%) | ||||
| 8 of 8 HLA matched | 122 (64) | 80 (61) | 225 (57) | .31 |
| 1 or 2 loci mismatched | 69 (36) | 52 (39) | 167 (43) | |
| Donor-recipient sex match, n (%) | ||||
| Male donor/male recipient | 89 (47) | 47 (36) | 157 (40) | .24 |
| Male donor/female recipient | 39 (20) | 29 (22) | 83 (21) | |
| Female donor/male recipient | 36 (19) | 27 (20) | 90 (23) | |
| Female donor/female recipient | 24 (13) | 29 (22) | 62 (16) | |
| Not reported | 3 (2) | |||
| Donor-recipient CMV status, n (%) | ||||
| Donor seronegative/recipient seronegative | 57 (30) | 49 (37) | 142 (36) | .01 |
| Donor seropositive/recipient seronegative | 29 (15) | 31 (23) | 83 (21) | |
| Donor seronegative/recipient seropositive | 72 (38) | 27 (20) | 95 (24) | |
| Donor seropositive /recipient seropositive | 28 (15) | 21 (16) | 65 (17) | |
| Not reported | 5 (3) | 4 (3) | 7 (2) | |
| Year of transplantation, n (%) | ||||
| 1998-2003 | 100 (52) | 56 (42) | 246 (63) | < .001 |
| 2004-2007 | 91 (48) | 76 (58) | 146 (37) | |
| Median follow-up of survivors, mo (range) | 42 (3-132) | 58 (8-125) | 60 (4-131) | |
| . | ATG . | Alemtuzumab . | T cell–replete . | P . |
|---|---|---|---|---|
| No. of patients | 191 | 132 | 392 | |
| Age at transplantation, y | ||||
| Median (range) | 10 (1-18) | 9 (< 1-18) | 10 (< 1-18) | .10 |
| 1-5, n (%) | 18 (9) | 19 (14) | 65 (17) | |
| 6-10, n (%) | 78 (41) | 58 (44) | 141 (36) | |
| 11-18, n (%) | 95 (50) | 55 (42) | 186 (47) | |
| Male sex, n (%) | 128 (67) | 74 (56) | 247 (63) | .13 |
| FAB subtype, n (%) | ||||
| Pre-B | 144 (75) | 115 (87) | 336 (86) | .001 |
| B cell | 3 ( 2) | 1 ( 1) | 6 ( 2) | |
| T cell | 36 (19) | 13 (10) | 32 ( 8) | |
| Not reported | 8 ( 4) | 3 ( 2) | 18 ( 5) | |
| Cytogenetic risk group, n (%)* | ||||
| Standard-risk | 111(58) | 81 (62) | 209 (53) | |
| Poor-risk | 33 (17) | 37 (28) | 72 (18) | |
| Not reported | 47 (25) | 14 (11) | 111 (28) | |
| Disease status at transplantation, n (%) | ||||
| 1st CR | 53 (28) | 31 (23) | 91 (23) | .67 |
| 2nd CR | 87 (46) | 72 (55) | 200 (51) | |
| 3rd and beyond CR | 34 (18) | 22 (17) | 68 (17) | |
| Primary induction failure/relapse | 17 (9) | 7 (5) | 33 (8) | |
| Conditioning regimen, n (%) | ||||
| TBI + cyclophosphamide + other agents† | 70 (37) | 3 (2) | 54 (14) | < .001 |
| TBI + cyclophosphamide‡ | 85 (45) | 122 (92) | 311 (79) | |
| TBI + other agents§ | 36 (19) | 7 (5) | 27 (7) | |
| TBI dose, cGy, n (%) | ||||
| 1000 | 4 ( 2) | 31 ( 7) | < .001 | |
| 1200 | 162 (85) | 17 (13) | 155 (40) | |
| 1320 | 11 ( 6) | 90 (23) | ||
| 1400 | 13 ( 7) | 44 (33) | 93 (24) | |
| 1440 | 1 (< 1) | 71 (54) | 23 ( 6) | |
| Graft type, n (%) | ||||
| BM | 148 (77) | 111 (84) | 329 (84) | .13 |
| Peripheral blood | 43 (23) | 21 (16) | 63 (16) | |
| GVHD prophylaxis, n (%) | ||||
| Tacrolimus-containing regimen | 36 (19) | 53 (40) | 103 (27) | < .001 |
| Cyclosporine-containing regimen | 155 (81) | 79 (60) | 289 (73) | |
| Donor-recipient HLA match, n (%) | ||||
| 8 of 8 HLA matched | 122 (64) | 80 (61) | 225 (57) | .31 |
| 1 or 2 loci mismatched | 69 (36) | 52 (39) | 167 (43) | |
| Donor-recipient sex match, n (%) | ||||
| Male donor/male recipient | 89 (47) | 47 (36) | 157 (40) | .24 |
| Male donor/female recipient | 39 (20) | 29 (22) | 83 (21) | |
| Female donor/male recipient | 36 (19) | 27 (20) | 90 (23) | |
| Female donor/female recipient | 24 (13) | 29 (22) | 62 (16) | |
| Not reported | 3 (2) | |||
| Donor-recipient CMV status, n (%) | ||||
| Donor seronegative/recipient seronegative | 57 (30) | 49 (37) | 142 (36) | .01 |
| Donor seropositive/recipient seronegative | 29 (15) | 31 (23) | 83 (21) | |
| Donor seronegative/recipient seropositive | 72 (38) | 27 (20) | 95 (24) | |
| Donor seropositive /recipient seropositive | 28 (15) | 21 (16) | 65 (17) | |
| Not reported | 5 (3) | 4 (3) | 7 (2) | |
| Year of transplantation, n (%) | ||||
| 1998-2003 | 100 (52) | 56 (42) | 246 (63) | < .001 |
| 2004-2007 | 91 (48) | 76 (58) | 146 (37) | |
| Median follow-up of survivors, mo (range) | 42 (3-132) | 58 (8-125) | 60 (4-131) | |
FAB indicates French-American-British.
Poor risk was defined as presence of Philadelphia chromosome, translocation (4;11), hypodiploid (< 44), and iAMP21; standard risk was defined as all other abnormalities and normal cytogenetics.
Cyclophosphamide dose, 120 mg/kg; 35 of 70 patients in the ATG group received thiotepa (150-350 mg/m2) and 35 patients received etoposide (1-2 G/m2). One patient in the alemtuzumab group received thiotepa (500 mg/m2) and 2 patients received etoposide (1.5 G/m2). Five patients in the T cell–replete group received thiotepa (300 mg/m2) and 49 patients received etoposide (1-2 G/m2).
Cyclophosphamide dose was 120 mg/kg.
Thirty-one of 36 patients in the ATG group received etoposide (1-2.5 G/m2), 3 patients received melphalan (125 or 140 mg/m2), and 2 patients received thiotepa (300 mg/m2). All 7 patients in the alemtuzumab group received etoposide (1-2.5 G/m2). Thirteen patients in the T cell–replete group received etoposide (1-2.5 G/m2), 8 patients received cytosine arabinoside (3.5 G/m2), 5 patients received melphalan (140 mg/m2), and 1 patient received thiotepa (300 mg/m2).