Table 1.

Clinical characteristics of the patients in the 2 arms of the study

Randomization armP
CsACsA/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 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 armP
CsACsA/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 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.

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