Table 2.

GVHD response to denileukin diftitox by dose level, organ involvement, and severity.




CR, no. (%)

PR, no. (%)

OR, no. (%)
Drug dose    
Level 1   1/7 (14)   4/7 (57)   5/7 (71)  
Level 2   6/13 (46)   3/13 (23)   9/13 (69)  
Level 3*  1/4 (25)   2/4 (50)   3/4 (75)  
Overall   8/24 (33)   9/24 (38)  17/24 (71)  
Organs involved    
Skin   7/16 (44)   4/16 (25)   11/16 (69)  
Intestine   9/16 (56)   3/16 (19)   12/16 (75)  
Liver   1/4 (25)   0   1/4 (25)  
GVHD grade at enrollment    
II   1/8 (13)   4/8 (50)   5/8 (63)  
III   5/13 (38)   4/13 (31)   9/13 (69)  
IV
 
2/3 (67)
 
1/3 (33)
 
3/3 (100)
 



CR, no. (%)

PR, no. (%)

OR, no. (%)
Drug dose    
Level 1   1/7 (14)   4/7 (57)   5/7 (71)  
Level 2   6/13 (46)   3/13 (23)   9/13 (69)  
Level 3*  1/4 (25)   2/4 (50)   3/4 (75)  
Overall   8/24 (33)   9/24 (38)  17/24 (71)  
Organs involved    
Skin   7/16 (44)   4/16 (25)   11/16 (69)  
Intestine   9/16 (56)   3/16 (19)   12/16 (75)  
Liver   1/4 (25)   0   1/4 (25)  
GVHD grade at enrollment    
II   1/8 (13)   4/8 (50)   5/8 (63)  
III   5/13 (38)   4/13 (31)   9/13 (69)  
IV
 
2/3 (67)
 
1/3 (33)
 
3/3 (100)
 
*

Only 1 patient at this level completed the intended 10 doses due to toxicity.

Four of 9 patients with a PR converted to CR after day 29 without additional therapy.

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