Table 3.

Single-agent monoclonal antibody trials.

StudyMonoclonal AntibodyPrior RxNo. Pts. Evaluable% CR% ORMedian TTP (mo)
Abbreviations: Rx, treatment; CR, complete remission; OR, overall response; IV, intravenous; SQ, subcutaneous; TIW, thrice weekly; NA, not available; NR, not reached; TTP, time-to-progression for responders 
* Fludarabine refractory 
** Three patients received 250 mg/m2 TIW for 4 weeks 
*** Updated as presented 
 Alemtuzumab      
Keating21  30 mg IV TIW × 12 wk Yes* 93 33 
Osterborg22  30 mg IV TIW × 12 wk Yes 29 42 12 
Rai23  30 mg IV TIW × 16 wk Yes 24 33 19.6 
Ferrajoli24  30 mg IV TIW × 12 wk Yes 42 31 NA 
Moreton5  30 mg IV TIW × 16 wk Yes 91 35 54 NA 
Stilgenbauer25  30 mg SQ TIW × 12 wk Yes* 44 36 10 
Lundin26  30 mg SQ TIW × 18 wk No 41 19 87 NR 
 Rituximab      
McLaughlin30  375 mg/m2 IV weekly × 4 Yes 30 13 NA 
Huhn32  375 mg/m2 IV weekly × 4 Yes 28 25 
O’Brien33  500–825 mg/m2 IV weekly × 4 Yes 24 21  
 1000–1500 mg/m2 IV weekly × 4 Yes 43 
 2250 mg/m2 IV weekly × 4 Yes 75  
Byrd34  375 mg/m2 IV TIW × 4 wk** No/Yes 29 52 11 
Hainsworth59  375 mg/m2 IV weekly × 4 then q 6 mo for 2 yr No 43 58 19 
StudyMonoclonal AntibodyPrior RxNo. Pts. Evaluable% CR% ORMedian TTP (mo)
Abbreviations: Rx, treatment; CR, complete remission; OR, overall response; IV, intravenous; SQ, subcutaneous; TIW, thrice weekly; NA, not available; NR, not reached; TTP, time-to-progression for responders 
* Fludarabine refractory 
** Three patients received 250 mg/m2 TIW for 4 weeks 
*** Updated as presented 
 Alemtuzumab      
Keating21  30 mg IV TIW × 12 wk Yes* 93 33 
Osterborg22  30 mg IV TIW × 12 wk Yes 29 42 12 
Rai23  30 mg IV TIW × 16 wk Yes 24 33 19.6 
Ferrajoli24  30 mg IV TIW × 12 wk Yes 42 31 NA 
Moreton5  30 mg IV TIW × 16 wk Yes 91 35 54 NA 
Stilgenbauer25  30 mg SQ TIW × 12 wk Yes* 44 36 10 
Lundin26  30 mg SQ TIW × 18 wk No 41 19 87 NR 
 Rituximab      
McLaughlin30  375 mg/m2 IV weekly × 4 Yes 30 13 NA 
Huhn32  375 mg/m2 IV weekly × 4 Yes 28 25 
O’Brien33  500–825 mg/m2 IV weekly × 4 Yes 24 21  
 1000–1500 mg/m2 IV weekly × 4 Yes 43 
 2250 mg/m2 IV weekly × 4 Yes 75  
Byrd34  375 mg/m2 IV TIW × 4 wk** No/Yes 29 52 11 
Hainsworth59  375 mg/m2 IV weekly × 4 then q 6 mo for 2 yr No 43 58 19 

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