Table 1.

Treatment in CALGB 10404

Time*Arm A: FRArm B: FR+LArm C: FCRArm D: FCR+L
Month 1 Fludarabine 25 mg/m2 IV days 1-5 Fludarabine 25 mg/m2 IV days 1-5 Fludarabine 25 mg/m2 IV days 1-3† NA 
Rituximab 50 mg/m2 IVPB day 1 Rituximab 50 mg/m2 IVPB day 1 Cyclophosphamide 250 mg/m2 days 1-3† 
Rituximab 325 mg/m2 IVPB day 3 Rituximab 325 mg/m2 IVPB day 3 Rituximab 50 mg/m2 IVPB day 1 
Rituximab 375 mg/m2 IVPB day 5 Rituximab 375 mg/m2 IVPB day 5 Rituximab 325 mg/m2 IVPB day 2 
Months 2-6 Fludarabine 25 mg/m2 IV days 1-5 Fludarabine 25 mg/m2 IV days 1-5 Fludarabine 25 mg/m2 IV days 1-3† Fludarabine 25 mg/m2 IV days 1-3† 
Rituximab 375 mg/m2 IVPB day 1 Rituximab 375 mg/m2 IVPB day 1 Cyclophosphamide 250 mg/m2 days 1-3† Cyclophosphamide 250 mg/m2 days 1-3† 
Rituximab 500 mg/m2 IVPB day 1 Rituximab 500 mg/m2 IVPB day 1 
End of 9 mo Full staging Full staging Full staging Full staging 
Month 10 NA Lenalidomide 5 mg by mouth days 1-21 NA Lenalidomide 5 mg by mouth days 1-21 
Months 11-15 NA Lenalidomide 10 mg by mouth days 1-21 NA Lenalidomide 10 mg by mouth days 1-21 
End of 18 mo NA Full staging NA Full staging 
End of 24 mo Full staging Full staging Full staging Full staging 
Time*Arm A: FRArm B: FR+LArm C: FCRArm D: FCR+L
Month 1 Fludarabine 25 mg/m2 IV days 1-5 Fludarabine 25 mg/m2 IV days 1-5 Fludarabine 25 mg/m2 IV days 1-3† NA 
Rituximab 50 mg/m2 IVPB day 1 Rituximab 50 mg/m2 IVPB day 1 Cyclophosphamide 250 mg/m2 days 1-3† 
Rituximab 325 mg/m2 IVPB day 3 Rituximab 325 mg/m2 IVPB day 3 Rituximab 50 mg/m2 IVPB day 1 
Rituximab 375 mg/m2 IVPB day 5 Rituximab 375 mg/m2 IVPB day 5 Rituximab 325 mg/m2 IVPB day 2 
Months 2-6 Fludarabine 25 mg/m2 IV days 1-5 Fludarabine 25 mg/m2 IV days 1-5 Fludarabine 25 mg/m2 IV days 1-3† Fludarabine 25 mg/m2 IV days 1-3† 
Rituximab 375 mg/m2 IVPB day 1 Rituximab 375 mg/m2 IVPB day 1 Cyclophosphamide 250 mg/m2 days 1-3† Cyclophosphamide 250 mg/m2 days 1-3† 
Rituximab 500 mg/m2 IVPB day 1 Rituximab 500 mg/m2 IVPB day 1 
End of 9 mo Full staging Full staging Full staging Full staging 
Month 10 NA Lenalidomide 5 mg by mouth days 1-21 NA Lenalidomide 5 mg by mouth days 1-21 
Months 11-15 NA Lenalidomide 10 mg by mouth days 1-21 NA Lenalidomide 10 mg by mouth days 1-21 
End of 18 mo NA Full staging NA Full staging 
End of 24 mo Full staging Full staging Full staging Full staging 

Patients with del(11q) disease initially randomized to arms A or B were reassigned to arm D after the first month.

IVPB, IV piggyback; NA, not applicable.

*

Each cycle of therapy was 28 days.

†

Patients 70 years of age and older received fludarabine 20 mg/m2 and cyclophosphamide 150 mg/m2.

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