Detailed outcome of the patients enrolled
| . | Total (71 patients) . | Randomization arm . | P . | |
|---|---|---|---|---|
| CsA (34 patients) . | CsA/MTX (37 patients) . | |||
| Engraftment: | ||||
| Engraftment | 68 (99%) | 32 (100%) | 36 (97%) | |
| Rejection | 1 (1%) | 0 (0%) | 1 (3%) | NS |
| Not evaluable | 2 | 2 | 0 | |
| Late marrow failure | 5 (7%) | 2 (6%) | 3 (8%) | NS |
| Autologous reconstitution | 5 (7%) | 2 (6%) | 3 (8%) | NS |
| Chimerism: | ||||
| Donor | 54 (76%) | 26 (76%) | 28 (76%) | |
| Mixed | 9 (13%) | 4 (12%) | 5 (13%) | NS |
| Recipient4-150 | 6 (8%) | 2 (6%) | 4 (11%) | |
| Not evaluable | 2 (3%) | 2 (6%) | 0 (0%) | |
| Patients who achieved transfusion independence: | ||||
| With donor chimerism after 1st BMT | 61 (86%) | 29 (85%) | 32 (86%) | |
| With donor chimerism after 2nd BMT | 2 (3%) | 0 (0%) | 2 (5%) | NS |
| With autologous reconstitution | 3 (4%) | 1 (3%) | 2 (5%) | |
| Total | 66 (93%) | 30 (88%) | 36 (97%) | |
| Transplant-related death: | ||||
| Within 100 days | 2 (3%) | 2 (6%) | 0 (0%) | |
| Within 1 year after BMT | 6 (8%) | 5 (15%) | 1 (3%) | NS |
| Total | 8 (11%) | 6 (18%) | 2 (5%) | |
| Patients alive | 62 (87%) | 27 (79%) | 35 (95%) | .058 |
| Patients alive, transfusion independent and with donor engraftment: | ||||
| After 1st BMT | 57 (80%) | 26 (76%) | 31 (84%) | |
| After 2nd BMT | 2 (3%) | 0 (0%) | 2 (5%) | NS |
| Total | 59 (83%) | 26 (76%) | 33 (89%) | |
| . | Total (71 patients) . | Randomization arm . | P . | |
|---|---|---|---|---|
| CsA (34 patients) . | CsA/MTX (37 patients) . | |||
| Engraftment: | ||||
| Engraftment | 68 (99%) | 32 (100%) | 36 (97%) | |
| Rejection | 1 (1%) | 0 (0%) | 1 (3%) | NS |
| Not evaluable | 2 | 2 | 0 | |
| Late marrow failure | 5 (7%) | 2 (6%) | 3 (8%) | NS |
| Autologous reconstitution | 5 (7%) | 2 (6%) | 3 (8%) | NS |
| Chimerism: | ||||
| Donor | 54 (76%) | 26 (76%) | 28 (76%) | |
| Mixed | 9 (13%) | 4 (12%) | 5 (13%) | NS |
| Recipient4-150 | 6 (8%) | 2 (6%) | 4 (11%) | |
| Not evaluable | 2 (3%) | 2 (6%) | 0 (0%) | |
| Patients who achieved transfusion independence: | ||||
| With donor chimerism after 1st BMT | 61 (86%) | 29 (85%) | 32 (86%) | |
| With donor chimerism after 2nd BMT | 2 (3%) | 0 (0%) | 2 (5%) | NS |
| With autologous reconstitution | 3 (4%) | 1 (3%) | 2 (5%) | |
| Total | 66 (93%) | 30 (88%) | 36 (97%) | |
| Transplant-related death: | ||||
| Within 100 days | 2 (3%) | 2 (6%) | 0 (0%) | |
| Within 1 year after BMT | 6 (8%) | 5 (15%) | 1 (3%) | NS |
| Total | 8 (11%) | 6 (18%) | 2 (5%) | |
| Patients alive | 62 (87%) | 27 (79%) | 35 (95%) | .058 |
| Patients alive, transfusion independent and with donor engraftment: | ||||
| After 1st BMT | 57 (80%) | 26 (76%) | 31 (84%) | |
| After 2nd BMT | 2 (3%) | 0 (0%) | 2 (5%) | NS |
| Total | 59 (83%) | 26 (76%) | 33 (89%) | |
Two patients in the CsA/MTX group achieved complete donor chimerism after a second BMT from the same donor of the first transplant.