Table 1.
Patient Characteristics
| Characteristic | Randomized Patients (n = 210)* | ||
|---|---|---|---|
| Arm A (Placebo; n = 65) | Arm B (0.3 mg/kg Daclizumab; n = 69) | Arm C (1.2 mg/kg Daclizumab; n = 76) | |
| Study site, n (%) | |||
| FHCRC | 35 (54) | 34 (49) | 39 (51) |
| United States, non-FHCRC | 16(24) | 19(28) | 19(25) |
| Non-US centers | 14(22) | 16(23) | 18(24) |
| Patient sex, n (%) | |||
| Female | 19(29) | 23 (33) | 40 (53) |
| Male | 46(71) | 46 (67) | 36 (47) |
| Donor sex, n (%) | |||
| Female | 28 (43) | 26 (38) | 30 (39) |
| Male | 37 (57) | 43 (62) | 46 (61) |
| HLA matching, | |||
| n(%) | |||
| Matched | 45 (69) | 51 (74) | 53 (70) |
| Mismatched | 20(31) | 18(26) | 23 (30) |
| Diagnosis, n (%) | |||
| ALL | 11 (17) | 11 (16) | 9(12) |
| AML | 6 (9) | 11 (16) | 13(17) |
| CML | 35 (54) | 37 (54) | 47 (62) |
| MDS | 9 (14) | 5(7) | 2 (3) |
| Other | 4 (6) | 5(7) | 5 (7) |
| Disease risk†,‡, n(%) | |||
| High | 31 (48) | 30 (43) | 33 (43)‡ |
| Low | 34 (52) | 39 (57) | 41 (54)‡ |
| Age | |||
| Median (range), yr | 35 (3–54) | 31 (1–52) | 30(1–54) |
| <20 yr, n (%) | 13(20) | 13(19) | 17(22) |
| ≥20 yr, n (%) | 52 (80) | 56(81) | 59 (78) |
| Cytomegalovirus serology, donor/patient, n (%) | |||
| +/− | 16(25) | 23 (34) | 19(25) |
| −/+ | 18(28) | 18(26) | 26 (34) |
| +/− | 11 (17) | 7(10) | 11 (14) |
| −/− | 20(31) | 20 (29) | 20 (26) |
| Doses of study treatment, n (%) | |||
| 5 | 62 (95) | 63 (91) | 68 (89) |
| <5 | 3 (5) | 6(9) | 8(11) |
FHCRC indicates Fred Hutchinson Cancer Research Center; ALL, acute lymphoblastic leukemia; AML, acute myelogenous leukemia; CML, chronic myelogenous leukemia; MDS, myelodysplastic syndrome.
Baseline characteristics are inclusive of all randomized patients (n = 210).
Disease risk defined as follows: high risk, acute leukemia in relapse or greater than second remission, transfusion-dependent aplastic anemia, CML beyond first chronic phase, and MDS with refractory anemia with excess blasts or refractory anemia with excess blasts in transformation; low risk, acute leukemia in first or second remission, non–transfusion-dependent aplastic anemia, CML in first chronic phase, and MDS with refractory anemia.
Risk category data not available for 2 patients.