Table 1. Demographic and Baseline Characteristics (Treated Population) of All Patients and by Treatment Arm.
Characteristic | Arm A (n = 75) | Arm B (n = 74) | All Patients (n = 149) |
---|---|---|---|
Age group, n (%) | |||
<18 years (pediatric) | 23 (31) | 25 (34) | 48 (32) |
≥18 years (adult) | 52 (69) | 49 (66) | 101 (68) |
Median age (range), years | 32 (0-61) | 34 (0-63) | 34 (0-63) |
Sex, n (%) | |||
Male | 41 (55) | 44 (59) | 85 (57) |
Female | 34 (45) | 30 (41) | 64 (43) |
Weight, kg, median (range) | 65.9 (7-126) | 65.6 (4-111) | 65.8 (4-126) |
Eastern Cooperative Oncology Group performance status, n (%) | |||
≤2 | 9 (12) | 5 (7) | 14 (9) |
3 | 27 (36) | 28 (38) | 55 (37) |
4 | 17 (23) | 20 (27) | 37 (25) |
Unknown | 22 (29) | 21 (28) | 43 (29) |
Primary disease, n (%) | |||
Acute myelogenous leukemia | 18 (24) | 29 (39) | 47 (32) |
Acute lymphoblastic leukemia | 11 (15) | 4 (5) | 15 (10) |
Chronic myelogenous leukemia | 6 (8) | 4 (5) | 10 (7) |
Other leukemia | 1 (1) | 0 | 1 (1) |
Myelodysplastic syndrome | 10 (13) | 4 (5) | 14 (9) |
Non-Hodgkin lymphoma | 10 (13) | 9 (12) | 19 (13) |
Hodgkin lymphoma | 3 (4) | 6 (8) | 9 (6) |
Multiple myeloma | 1 (1) | 0 | 1 (1) |
Aplastic anemia | 1 (1) | 1 (1) | 2 (1) |
Neuroblastoma | 2 (3) | 3 (4) | 5 (3) |
Immunodeficiency | 3 (4) | 0 | 3 (2) |
Other | 9 (12) | 14 (19) | 23 (15) |
Previous treatment, n (%) | |||
Cyclophosphamide | 61 (81) | 58 (78) | 119 (80) |
Busulfan | 32 (43) | 31 (42) | 63 (42) |
Carmustine | 0 | 4 (5) | 4 (3) |
Etoposide | 7 (9) | 5 (7) | 12 (8) |
Melphalan | 8 (11) | 15 (20) | 23 (15) |
Total body irradiation | 33 (44) | 35 (47) | 68 (46) |
Cyclosporine | 38 (51) | 35 (47) | 73 (49) |
Methotrexate | 44 (59) | 38 (51) | 82 (55) |
Sirolimus | 13 (17) | 14 (19) | 27 (18) |
Tacrolimus | 30 (40) | 24 (32) | 54 (36) |
Gemtuzumab ozogamicin | 9 (12) | 11 (15) | 20 (13) |
Number of transplantations, n (%) | |||
1 | 68 (91) | 59 (80) | 127 (85) |
2 | 5 (7) | 13 (18) | 18 (12) |
3+ | 2 (3) | 2 (3) | 4 (3) |
Graft type, n (%) | |||
Autologous | 8 (11) | 12 (16) | 20 (13) |
Allogeneic | 67 (89) | 62 (84) | 129 (87) |
Days since transplantation, median (range)* | 19 (6-48) | 18 (0-60) | 18 (0-60) |
At randomization.