Baseline characteristics of the patients*
| Characteristic . | CsA/MPA (n = 52), n (%) . | PT-Cy/CsA (n = 99), n (%) . | P value . |
|---|---|---|---|
| Age (y), median (range) | 58 (26-70) | 57 (20-70) | .46 |
| Male sex | 33 (63) | 66 (67) | .69 |
| Diagnosis | |||
| Acute myeloid leukemia | 14 (27) | 30 (30) | .88 |
| Acute lymphoblastic leukemia | 7 (13) | 10 (10) | |
| Myelodysplastic syndrome | 8 (15) | 8 (8) | |
| Chronic myeloid leukemia | 1 (2) | 5 (5) | |
| Chronic lymphocytic leukemia | 2 (4) | 6 (6) | |
| Non-Hodgkin’s lymphoma | 10 (19) | 21 (21) | |
| Hodgkin’s lymphoma | 2 (4) | 3 (3) | |
| Myeloproliferative disease | 1 (2) | 3 (3) | |
| Multiple myeloma | 2 (4) | 7 (7) | |
| Other | 5 (10) | 6 (6) | |
| Donor type | |||
| MRD | 17 (33) | 30 (30) | .76 |
| MUD | 35 (67) | 69 (70) | |
| Female donor, male recipient pairs | 10 (19) | 17 (17) | .75 |
| Cytomegalovirus status | |||
| Recipient positive, donor positive | 16 (31) | 39 (39) | .54 |
| Recipient negative, donor negative | 21 (40) | 34 (34) | |
| Recipient positive, donor negative | 8 (15) | 18 (18) | |
| Recipient negative, donor positive | 7 (13) | 8 (8) | |
| Conditioning regimen | |||
| Myeloablative | 2 (4) | — | .22 |
| Reduced intensity | 1 (2) | 1 (1) | |
| Nonmyeloablative | 49 (94) | 98 (99) | |
| Source of stem cells | |||
| Bone marrow | — | 4 (4) | .30 |
| PB | 52 (100) | 95 (96) | |
| Infused CD34+ cells ×106/kg | |||
| Median | 6.0 | 6.3 | .93 |
| Range | 2.4-18.9 | 1.4-19.4 | |
| Infused CD3+ cells ×106/kg | |||
| Median | 232 | 230 | .42 |
| Range | (44-519) | (15-514) | |
| Characteristic . | CsA/MPA (n = 52), n (%) . | PT-Cy/CsA (n = 99), n (%) . | P value . |
|---|---|---|---|
| Age (y), median (range) | 58 (26-70) | 57 (20-70) | .46 |
| Male sex | 33 (63) | 66 (67) | .69 |
| Diagnosis | |||
| Acute myeloid leukemia | 14 (27) | 30 (30) | .88 |
| Acute lymphoblastic leukemia | 7 (13) | 10 (10) | |
| Myelodysplastic syndrome | 8 (15) | 8 (8) | |
| Chronic myeloid leukemia | 1 (2) | 5 (5) | |
| Chronic lymphocytic leukemia | 2 (4) | 6 (6) | |
| Non-Hodgkin’s lymphoma | 10 (19) | 21 (21) | |
| Hodgkin’s lymphoma | 2 (4) | 3 (3) | |
| Myeloproliferative disease | 1 (2) | 3 (3) | |
| Multiple myeloma | 2 (4) | 7 (7) | |
| Other | 5 (10) | 6 (6) | |
| Donor type | |||
| MRD | 17 (33) | 30 (30) | .76 |
| MUD | 35 (67) | 69 (70) | |
| Female donor, male recipient pairs | 10 (19) | 17 (17) | .75 |
| Cytomegalovirus status | |||
| Recipient positive, donor positive | 16 (31) | 39 (39) | .54 |
| Recipient negative, donor negative | 21 (40) | 34 (34) | |
| Recipient positive, donor negative | 8 (15) | 18 (18) | |
| Recipient negative, donor positive | 7 (13) | 8 (8) | |
| Conditioning regimen | |||
| Myeloablative | 2 (4) | — | .22 |
| Reduced intensity | 1 (2) | 1 (1) | |
| Nonmyeloablative | 49 (94) | 98 (99) | |
| Source of stem cells | |||
| Bone marrow | — | 4 (4) | .30 |
| PB | 52 (100) | 95 (96) | |
| Infused CD34+ cells ×106/kg | |||
| Median | 6.0 | 6.3 | .93 |
| Range | 2.4-18.9 | 1.4-19.4 | |
| Infused CD3+ cells ×106/kg | |||
| Median | 232 | 230 | .42 |
| Range | (44-519) | (15-514) | |
A total of 160 patients were randomized in the study; 9 patients were withdrawn from the analysis since they did not receive the stem cell transplantation.