Characteristics of patients according to randomization assignment
| Characteristic . | Placebo . | BDP . | Overall . |
|---|---|---|---|
| No. of patients | 67 | 62 | 129 |
| Age at randomization, y | |||
| Mean ± SD | 44.5 ± 13.4 | 45.9 ± 13.6 | 45.2 ± 13.5 |
| Median | 47.0 | 47.0 | 47.0 |
| Range | 17-66 | 6-70 | 6-70 |
| Sex, no. of patients (%) | |||
| Male | 41 (61) | 36 (58) | 77 (60) |
| Female | 26 (39) | 26 (42) | 52 (40) |
| Race, no. of patients (%) | |||
| White | 56 (84) | 54 (87) | 110 (85) |
| American Hispanic | 7 (10) | 4 (6) | 11 (9) |
| Asian | 1 (1) | 3 (5) | 4 (3) |
| Black | 3 (4) | 1 (2) | 4 (3) |
| Time from transplantation to randomization, d | |||
| Mean ± SD | 45.7 ± 31.80 | 48.3 ± 32.56 | 47.0 ± 32.07 |
| Median | 35.0 | 37.0 | 36.0 |
| Range | 18-171 | 18-190 | 18-190 |
| Primary diagnosis, no. of patients (%) | |||
| Acute myelogenous leukemia | 22 (33) | 19 (31) | 41 (32) |
| Acute lymphocytic leukemia | 7 (10) | 9 (14) | 16 (12) |
| Chronic myelogenous leukemia | 8 (12) | 8 (13) | 16 (12) |
| Non-Hodgkin lymphoma | 7 (10) | 6 (10) | 13 (10) |
| Myelodysplastic syndrome | 6 (9) | 2 (3) | 8 (6) |
| Multiple myeloma | 1 (1) | 6 (10) | 7 (5) |
| Chronic lymphocytic leukemia | 4 (6) | 2 (3) | 6 (5) |
| Chronic myelomonocytic leukemia | 3 (5) | 2 (3) | 5 (4) |
| Aplastic anemia | 2 (3) | 1 (2) | 3 (2) |
| Hodgkin disease | 2 (3) | 1 (2) | 3 (2) |
| Myelofibrosis | 2 (3) | 1 (2) | 3 (2) |
| Acute promyelocytic leukemia | 0 (0) | 2 (3) | 2 (2) |
| Other* | 3 (5) | 3 (5) | 6 (5) |
| Risk of relapse after transplantation,† no. of patients (%) | |||
| High risk | 29 (43) | 40 (65) | 69 (53) |
| Low risk | 38 (57) | 22 (35) | 60 (47) |
| Source of donor cells, no. of patients (%) | |||
| Peripheral-blood stem cells | 62 (93) | 54 (87) | 116 (90) |
| Bone marrow | 5 (7) | 8 (13) | 13 (10) |
| Conditioning regimen, no. of patients (%) | |||
| Myeloablative | 52 (78) | 36 (58) | 88 (68) |
| Nonmyeloablative | 15 (22) | 26 (42) | 41 (32) |
| Patient/donor relationship, no. of patients (%) | |||
| Unrelated | 22 (33) | 19 (31) | 41 (32) |
| Related | 45 (67) | 43 (69) | 88 (68) |
| Biologic parent | 2 (3) | 0 (0) | 2 (2) |
| Sibling | 43 (64) | 40 (65) | 83 (64) |
| Other relation | 0 (0) | 3 (4) | 3 (2) |
| HLA allele match status in siblings, no. of patients (%) | |||
| Matched | 43 (64) | 39 (63) | 82 (64) |
| Mismatched for 1 or more alleles | 0 (0) | 1 (2) | 1 (< 1) |
| Characteristic . | Placebo . | BDP . | Overall . |
|---|---|---|---|
| No. of patients | 67 | 62 | 129 |
| Age at randomization, y | |||
| Mean ± SD | 44.5 ± 13.4 | 45.9 ± 13.6 | 45.2 ± 13.5 |
| Median | 47.0 | 47.0 | 47.0 |
| Range | 17-66 | 6-70 | 6-70 |
| Sex, no. of patients (%) | |||
| Male | 41 (61) | 36 (58) | 77 (60) |
| Female | 26 (39) | 26 (42) | 52 (40) |
| Race, no. of patients (%) | |||
| White | 56 (84) | 54 (87) | 110 (85) |
| American Hispanic | 7 (10) | 4 (6) | 11 (9) |
| Asian | 1 (1) | 3 (5) | 4 (3) |
| Black | 3 (4) | 1 (2) | 4 (3) |
| Time from transplantation to randomization, d | |||
| Mean ± SD | 45.7 ± 31.80 | 48.3 ± 32.56 | 47.0 ± 32.07 |
| Median | 35.0 | 37.0 | 36.0 |
| Range | 18-171 | 18-190 | 18-190 |
| Primary diagnosis, no. of patients (%) | |||
| Acute myelogenous leukemia | 22 (33) | 19 (31) | 41 (32) |
| Acute lymphocytic leukemia | 7 (10) | 9 (14) | 16 (12) |
| Chronic myelogenous leukemia | 8 (12) | 8 (13) | 16 (12) |
| Non-Hodgkin lymphoma | 7 (10) | 6 (10) | 13 (10) |
| Myelodysplastic syndrome | 6 (9) | 2 (3) | 8 (6) |
| Multiple myeloma | 1 (1) | 6 (10) | 7 (5) |
| Chronic lymphocytic leukemia | 4 (6) | 2 (3) | 6 (5) |
| Chronic myelomonocytic leukemia | 3 (5) | 2 (3) | 5 (4) |
| Aplastic anemia | 2 (3) | 1 (2) | 3 (2) |
| Hodgkin disease | 2 (3) | 1 (2) | 3 (2) |
| Myelofibrosis | 2 (3) | 1 (2) | 3 (2) |
| Acute promyelocytic leukemia | 0 (0) | 2 (3) | 2 (2) |
| Other* | 3 (5) | 3 (5) | 6 (5) |
| Risk of relapse after transplantation,† no. of patients (%) | |||
| High risk | 29 (43) | 40 (65) | 69 (53) |
| Low risk | 38 (57) | 22 (35) | 60 (47) |
| Source of donor cells, no. of patients (%) | |||
| Peripheral-blood stem cells | 62 (93) | 54 (87) | 116 (90) |
| Bone marrow | 5 (7) | 8 (13) | 13 (10) |
| Conditioning regimen, no. of patients (%) | |||
| Myeloablative | 52 (78) | 36 (58) | 88 (68) |
| Nonmyeloablative | 15 (22) | 26 (42) | 41 (32) |
| Patient/donor relationship, no. of patients (%) | |||
| Unrelated | 22 (33) | 19 (31) | 41 (32) |
| Related | 45 (67) | 43 (69) | 88 (68) |
| Biologic parent | 2 (3) | 0 (0) | 2 (2) |
| Sibling | 43 (64) | 40 (65) | 83 (64) |
| Other relation | 0 (0) | 3 (4) | 3 (2) |
| HLA allele match status in siblings, no. of patients (%) | |||
| Matched | 43 (64) | 39 (63) | 82 (64) |
| Mismatched for 1 or more alleles | 0 (0) | 1 (2) | 1 (< 1) |
Other primary diagnoses included (1 each) biphenotypic acute leukemia, extramedullary leukemia tumor, metastatic renal cell carcinoma, myeloproliferative syndrome, plasmacytic leukemia, and polycythemia vera.
Patients were considered to be at low risk of relapse following transplantation if the indication for transplantation was 1 of these diagnoses: aplastic anemia, chronic lymphocytic leukemia, chronic myelogenous leukemia in chronic phase, chronic myelomonocytic leukemia, acute myelogenous leukemia in first remission, myelodysplastic syndrome, myelofibrosis, myeloproliferative syndrome, or polycythemia vera. Patients with other diagnoses were considered to be at high risk for relapse after transplantation.