Clinical characteristics of the patients in the 2 arms of the study
| . | Randomization arm . | P . | |
|---|---|---|---|
| CsA . | CsA/MTX . | ||
| No. patients | 34 | 37 | |
| Recipient | |||
| Sex (M/F) | 19/15 | 26/11 | NS |
| Median age at diagnosis (years, range) | 18 (4–45) | 20 (6–43) | NS |
| Median age at BMT (years, range) | 18 (4–46) | 20 (7–43) | NS |
| Etiology | |||
| Idiopathic | 32 (94%) | 34 (92%) | NS |
| Post hepatitis | 2 (6%) | 3 (8%) | |
| Blood count at diagnosis (median value and range) | |||
| WBC (×109/L) | 1.9 (0.6–4.8) | 2.0 (0.2–7.0) | NS |
| PMN (×109/L) | 0.4 (0–1.2) | 0.5 (0–1.3) | NS |
| Hb (g/dL) | 8.0 (3.9–10.6) | 8.2 (4.2–13.0) | NS |
| Reticulocytes (×109/L) | 11 (0–19) | 11 (0–30) | NS |
| Platelets (×109/L) | 15 (1–49) | 11 (2–54) | NS |
| First-line treatment | |||
| None | 20 (59%) | 20 (54%) | |
| Immunosuppressive treatment | 13 (38%) | 14 (38%) | NS |
| Growth factors | 1 (3%) | 3 (8%) | |
| Interval diagnosis-BMT (months, median, and range) | 1.6 (0.6–36) | 2 (0.8–13) | NS |
| No. of patients not transfused before BMT | 0 | 1 | NS |
| No. of RBC transfusions before BMT | 6 (1–30) | 6 (0–29) | NS |
| No. of platelet transfusions before BMT | 7 (0–97) | 13 (0–133) | NS |
| Refractoriness to PLT transfusions | 11 (32%) | 6 (16%) | |
| Donor | |||
| Sex (M/F) | 18/16 | 21/16 | NS |
| Median age (years, range) | 18 (1–40) | 19 (6–50) | NS |
| Sex match | 23 (67%) | 22 (59%) | |
| Sex mismatch | |||
| Male donor/female recipient | 5 (15%) | 5 (14%) | NS |
| Female donor/male recipient | 6 (18%) | 10 (27%) | |
| Donor/recipient blood group compatibility | |||
| Compatibility | 25 (73%) | 26 (70%) | |
| Minor incompatibility | 3 (9%) | 7 (19%) | NS |
| Major incompatibility | 6 (18%) | 4 (11%) | |
| HCMV serology | |||
| Negative donor/negative recipient | 6 (18%) | 5 (13%) | |
| Positive donor/negative recipient | 3 (9%) | 8 (22%) | NS |
| Negative donor/positive recipient | 7 (20%) | 8 (22%) | |
| Positive donor/positive recipient | 18 (53%) | 16 (43%) | |
| Median number of cells infused and range (×108/kg) | 3.7 (1.1–10.4) | 4.1 (1.4–12.5) | NS |
| Post-BMT growth factors | |||
| None | 19 (56%) | 30 (81%) | |
| EPO | 1 (3%) | 1 (3%) | .062 |
| G-CSF | 14 (41%) | 6 (16%) | |
| . | Randomization arm . | P . | |
|---|---|---|---|
| CsA . | CsA/MTX . | ||
| No. patients | 34 | 37 | |
| Recipient | |||
| Sex (M/F) | 19/15 | 26/11 | NS |
| Median age at diagnosis (years, range) | 18 (4–45) | 20 (6–43) | NS |
| Median age at BMT (years, range) | 18 (4–46) | 20 (7–43) | NS |
| Etiology | |||
| Idiopathic | 32 (94%) | 34 (92%) | NS |
| Post hepatitis | 2 (6%) | 3 (8%) | |
| Blood count at diagnosis (median value and range) | |||
| WBC (×109/L) | 1.9 (0.6–4.8) | 2.0 (0.2–7.0) | NS |
| PMN (×109/L) | 0.4 (0–1.2) | 0.5 (0–1.3) | NS |
| Hb (g/dL) | 8.0 (3.9–10.6) | 8.2 (4.2–13.0) | NS |
| Reticulocytes (×109/L) | 11 (0–19) | 11 (0–30) | NS |
| Platelets (×109/L) | 15 (1–49) | 11 (2–54) | NS |
| First-line treatment | |||
| None | 20 (59%) | 20 (54%) | |
| Immunosuppressive treatment | 13 (38%) | 14 (38%) | NS |
| Growth factors | 1 (3%) | 3 (8%) | |
| Interval diagnosis-BMT (months, median, and range) | 1.6 (0.6–36) | 2 (0.8–13) | NS |
| No. of patients not transfused before BMT | 0 | 1 | NS |
| No. of RBC transfusions before BMT | 6 (1–30) | 6 (0–29) | NS |
| No. of platelet transfusions before BMT | 7 (0–97) | 13 (0–133) | NS |
| Refractoriness to PLT transfusions | 11 (32%) | 6 (16%) | |
| Donor | |||
| Sex (M/F) | 18/16 | 21/16 | NS |
| Median age (years, range) | 18 (1–40) | 19 (6–50) | NS |
| Sex match | 23 (67%) | 22 (59%) | |
| Sex mismatch | |||
| Male donor/female recipient | 5 (15%) | 5 (14%) | NS |
| Female donor/male recipient | 6 (18%) | 10 (27%) | |
| Donor/recipient blood group compatibility | |||
| Compatibility | 25 (73%) | 26 (70%) | |
| Minor incompatibility | 3 (9%) | 7 (19%) | NS |
| Major incompatibility | 6 (18%) | 4 (11%) | |
| HCMV serology | |||
| Negative donor/negative recipient | 6 (18%) | 5 (13%) | |
| Positive donor/negative recipient | 3 (9%) | 8 (22%) | NS |
| Negative donor/positive recipient | 7 (20%) | 8 (22%) | |
| Positive donor/positive recipient | 18 (53%) | 16 (43%) | |
| Median number of cells infused and range (×108/kg) | 3.7 (1.1–10.4) | 4.1 (1.4–12.5) | NS |
| Post-BMT growth factors | |||
| None | 19 (56%) | 30 (81%) | |
| EPO | 1 (3%) | 1 (3%) | .062 |
| G-CSF | 14 (41%) | 6 (16%) | |
Data are expressed as median and range. P values were calculated using the Mann-Whitney U rank-sum test, the Student t test, χ2 analysis, or the Fisher exact test, as appropriate.
BMT, bone marrow transplantation; WBC, white blood cell; PMN, polymorphonuclear granulocyte; RBC, red blood cell; PLT, platelet; HCMV, human cytomegalovirus; EPO, erythropoietin; G-CSF, granulocyte–colony-stimulating factor; NS, not significant.