Table 2

Phase 2 studies of cladribine combinations in indolent NHL

StudyCladribine and other agent dosesOther agentsHistology, %
Prior treatment, %OR, %CR, %Median duration, mo
FollicularNon
Saven et al (1996)38  Mitoxantrone 57 43 100 70 22 5 (PR), 15 (CR) 
Laurencet et al (1999)39  Cyclophosphamide, prednisone 100 42 88 22 12 (PR), 15 (CR) 
Robak et al (1999)40  Mitoxantrone, dexamethasone 100 100 29 > 6 
Rummel et al (2002)41  Mitoxantrone 51 49 32 90 44 24 
Van Den Neste et al (2004)37  Cyclophosphamide 26 74 100 51 14 11 
Robak et al (2004)42  Rituximab 12 88 100 69 15 
Robak et al (2006)43  Rituximab, cyclophosphamide 100§ 100 71 11 11 
Laurencet et al (2007)44  Cyclophosphamide, prednisone 100 61 75 30 
Inwards et al (2008)45  (Study N0198) Rituximab 100 100 66 52 12 
StudyCladribine and other agent dosesOther agentsHistology, %
Prior treatment, %OR, %CR, %Median duration, mo
FollicularNon
Saven et al (1996)38  Mitoxantrone 57 43 100 70 22 5 (PR), 15 (CR) 
Laurencet et al (1999)39  Cyclophosphamide, prednisone 100 42 88 22 12 (PR), 15 (CR) 
Robak et al (1999)40  Mitoxantrone, dexamethasone 100 100 29 > 6 
Rummel et al (2002)41  Mitoxantrone 51 49 32 90 44 24 
Van Den Neste et al (2004)37  Cyclophosphamide 26 74 100 51 14 11 
Robak et al (2004)42  Rituximab 12 88 100 69 15 
Robak et al (2006)43  Rituximab, cyclophosphamide 100§ 100 71 11 11 
Laurencet et al (2007)44  Cyclophosphamide, prednisone 100 61 75 30 
Inwards et al (2008)45  (Study N0198) Rituximab 100 100 66 52 12 

A indicates 0.1 mg/kg per day as continuous intravenous infusion for 7 days + mitoxantrone 5 mg/m2 intravenous day 1; B, 0.1 mg/kg per day subcutaneous bolus for 3 days; prednisone 40 mg/m2 PO for 5 days; cyclophosphamide 500 mg/m2 intravenous day 1; C, 0.12 mg/kg per day as 2-hour intravenous infusion for 5 consecutive days + mitoxantrone 10 mg/m2 + dexamethasone 20 mg/day intravenous/PO for 5 days; D, 5 mg/m2 2-hour intravenous infusion for 3 consecutive days + mitoxantrone 8 mg/m2 days 1 and 2, or 12 mg/m2 day 1 for first relapse; E, 5.6 mg/m2 per day for 3 days + cyclophosphamide 200 mg/m2 per day for 3 days; F, 0.12 mg/kg per day as 2-hour intravenous infusion for 5 consecutive days, days 2 to 6 + rituximab 375 mg/m2 as 6-hour intravenous infusion day 1; G, 0.12 mg/kg per day as 2-hour intravenous infusion for 3 consecutive days, days 2 to 4 + rituximab 375 mg/m2 as 6-hour intravenous infusion day 1 + cyclophosphamide 250 mg/m2 days 2 to 4; H, 0.1 mg/kg per day subcutaneous bolus injection for 5 days + prednisone 40 mg/m2 PO for 5 days + cyclophosphamide 500 mg/m2 intravenous day 1; and I, 5 mg/m2 2-hour intravenous infusion 5 consecutive days + rituximab 375 mg/m2 6-hour intravenous infusion day 1; and PR, partial response.

63% MCL.

65% CLL/small lymphocytic lymphoma.

§

17% MCL.

100% MCL.

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