Table 1.
Patient Characteristics
| Characteristic | All Patients (N = 147) |
Dose (mg/m2) |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control 0.0 (n = 37) |
Pentostatin |
|||||||||||
| 0.5 (n = 10) |
1.0 (n = 29) |
1.5 (n = 61) |
2.0 (n = 10) |
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| No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | |
| Age, years | ||||||||||||
| Median | 47 | 50 | 42 | 46 | 50 | 44 | ||||||
| Range | 18-72 | 18-69 | 23-55 | 20-71 | 22-72 | 31-59 | ||||||
| Sex | ||||||||||||
| Male | 83 | 56.5 | 22 | 59.5 | 7 | 70.0 | 18 | 62.1 | 33 | 54.1 | 3 | 30.0 |
| Female | 64 | 43.5 | 15 | 40.5 | 3 | 30.0 | 11 | 37.9 | 28 | 45.9 | 7 | 70.0 |
| Stem-cell source | ||||||||||||
| Peripheral blood | 28 | 19.0 | 8 | 21.6 | 0 | 8 | 27.6 | 11 | 18.0 | 1 | 10.0 | |
| Bone marrow | 119 | 81.0 | 29 | 78.4 | 10 | 100 | 21 | 72.4 | 50 | 82.0 | 9 | 90.0 |
| Conditioning regimen* | ||||||||||||
| BEAM | 2 | 1.4 | 0 | 1 | 10.0 | 0 | 0 | 1 | 10.0 | |||
| BU/FLU | 90 | 61.2 | 25 | 67.6 | 4 | 40.0 | 18 | 62.1 | 38 | 62.3 | 5 | 50.0 |
| BU/FLU/CLO | 3 | 2.0 | 1 | 2.7 | 0 | 0 | 2 | 3.3 | 0 | |||
| BU/CY | 14 | 9.5 | 2 | 5.4 | 3 | 30.0 | 4 | 13.8 | 3 | 4.9 | 2 | 20.0 |
| BU/MEL | 3 | 2.0 | 2 | 5.4 | 0 | 0 | 1 | 1.6 | 0 | |||
| CY/TBI | 14 | 9.5 | 4 | 10.8 | 0 | 1 | 3.5 | 7 | 11.5 | 2 | 20.0 | |
| FLU/MEL | 15 | 10.2 | 2 | 5.4 | 2 | 20.0 | 3 | 10.3 | 8 | 13.1 | 0 | |
| FLU/MEL/GO | 6 | 4.1 | 1 | 2.7 | 0 | 3 | 10.3 | 2 | 3.3 | 0 | ||
| BU-based | 112 | 76.2 | 30 | 81.1 | 8 | 80.0 | 22 | 75.9 | 44 | 72.1 | 8 | 80.0 |
| Regimen type | ||||||||||||
| Ablative | 112 | 76.2 | 28 | 75.7 | 7 | 70.0 | 24 | 82.8 | 45 | 73.8 | 8 | 80.0 |
| RIC | 35 | 23.8 | 9 | 24.3 | 3 | 30.0 | 5 | 17.2 | 16 | 26.2 | 2 | 20.0 |
| Donor | ||||||||||||
| Unrelated | 137 | 93.2 | 33 | 89.2 | 9 | 90.0 | 28 | 96.6 | 57 | 93.4 | 10 | 100 |
| Mismatched-related | 10 | 6.8 | 4 | 10.8 | 1 | 10.0 | 1 | 3.4 | 4 | 6.6 | 0 | |
| Antithymocyte globulin | 134 | 91.2 | 34 | 91.9 | 9 | 90.0 | 28 | 96.6 | 55 | 90.2 | 8 | 80.0 |
| Diagnosis | ||||||||||||
| AML | 84 | 57.1 | 15 | 40.5 | 6 | 60.0 | 23 | 79.3 | 35 | 57.4 | 5 | 50.0 |
| MDS | 21 | 14.3 | 8 | 21.6 | 0 | 1 | 3.5 | 12 | 19.7 | 0 | ||
| CML | 18 | 12.2 | 5 | 13.5 | 2 | 20.0 | 4 | 13.8 | 5 | 8.2 | 2 | 20.0 |
| ALL | 17 | 11.6 | 5 | 13.5 | 0 | 1 | 3.5 | 9 | 14.8 | 2 | 20.0 | |
| Lymphoma | 7 | 4.8 | 4 | 10.8 | 2 | 20.0 | 0 | 0 | 1 | 10.0 | ||
| HLA match | ||||||||||||
| 10/10 | 104 | 70.7 | 27 | 73.0 | 4 | 40.0 | 18 | 62.1 | 48 | 78.7 | 7 | 70.0 |
| 9/10 | 34 | 23.1 | 7 | 18.9 | 3 | 30.0 | 9 | 31.0 | 12 | 19.7 | 3 | 30.0 |
| 8/10 | 6 | 4.1 | 2 | 5.4 | 2 | 20.0 | 2 | 6.9 | 0 | 0 | ||
| 7/10 | 3 | 2.0 | 1 | 2.7 | 1 | 10.0 | 0 | 1 | 1.6 | 0 | ||
| Disease status at time of transplantation | ||||||||||||
| Complete remission | 67 | 45.6 | 15 | 40.5 | 4 | 40.0 | 14 | 48.3 | 29 | 47.5 | 5 | 50.0 |
| CML chronic phase | 9 | 6.1 | 1 | 2.7 | 0 | 2 | 6.9 | 4 | 6.6 | 2 | 20.0 | |
| Active disease | 71 | 48.3 | 21 | 56.8 | 6 | 60.0 | 13 | 44.8 | 28 | 45.9 | 3 | 30.0 |
| Risk group | ||||||||||||
| Low† | 40 | 27.2 | 8 | 21.6 | 0 | 9 | 31.0 | 19 | 31.2 | 4 | 40.0 | |
| High‡ | 107 | 72.8 | 29 | 78.4 | 10 | 100 | 20 | 69.0 | 42 | 68.9 | 6 | 60.0 |
| Graft characteristics (min-max) | ||||||||||||
| Total nucleated cells | ||||||||||||
| Median | 3.0 | 3.4 | 1.1 | 3.9 | 2.7 | 2.3 | ||||||
| Range | 0.2-554.1 | 0.6-21.3 | 0.8-4.4 | 0.3-22.8 | 0.2-16.3 | 0.6-5.54.1 | ||||||
| CD34 | ||||||||||||
| Median | 3.8 | 3.5 | 4.7 | 3.9 | 3.6 | 4.2 | ||||||
| Range | 1.1-29.3 | 1.4-12.7 | 1.7-6.9 | 1.3-29.3 | 1.1-12.4 | 1.6-7.7 | ||||||
| CD3 | ||||||||||||
| Median | 3.8 | 3.1 | 4.9 | 4.1 | 3.6 | 4.2 | ||||||
| Range | 0.9-29.3 | 1.4-12.7 | 0.9-6.9 | 1.3-29.3 | 1.1-12.4 | 1.6-7.7 | ||||||
Abbreviations: BEAM, carmustine, etoposide, cytarabine, melphalan; BU, busulfan; FLU, fludarabine; CLO, clofarabine; CY, cyclophosphamide; MEL, melphalan; TBI, total body irradiation; GO, gemtuzumab ozogamicin; RIC, reduced-intensity conditioning; AML, acute myeloid leukemia; MDS, myelodysplastic syndromes; CML, chronic myelogenous leukemia; ALL, acute lymphocytic leukemia.
Conditioning regimen: BU/MEL: busulfan 130 mg/m2 for 4 days, melphalan 70 mg/m2 for 2 days; FLU/MEL/MYLO: fludarabine 30 mg/m2 intravenously daily for 4 days, melphalan 140 mg/m2, gemtuzumab ozogamicin 2 mg/m2; BU/CY: busulfan 3.2 mg/kg intravenously daily for 4 days, cyclophosphamide 60 mg/kg for 2 days; BU/FLU: busulfan 130 mg/m2 intravenously daily for 4 days, fludarabine 40 mg/m2 intravenously daily for 4 days; CY/TBI: cyclophosphamide 120 mg/kg, total body irradiation at 12 Gy; BU/FLU/CLO: busulfan 130 mg/m2 intravenously daily for 4 days, fludarabine 40 mg/m2 for 4 days, clofarabine 40 mg/m2 intravenous daily for 4 days; BEAM: carmustine 300 mg/m2, etoposide 200 mg/m2 for 4 days, cytarabine 200 mg/m2 for4 days, melphalan 140 mg/m2 for 1 day; FLU/MEL: fludarabine 25 mg/m2 for 5 days, melphalan 70 mg/m2 for 2 days.
Low-risk: complete remission at the time of transplantation and no HLA mismatch.
High-risk: active disease at the time of transplantation or any HLA mismatch.