Table 1.

Treatment regimen

DayTreatment
−23 Alemtuzumab test dose 3 mg IV* 
−22 Alemtuzumab 10 mg IV 
−21 Alemtuzumab 15 mg IV 
−20 Alemtuzumab 20 mg IV 
−8 Fludarabine 30 mg/m2 IV 
−7 Fludarabine 30 mg/m2 IV 
−6 Fludarabine 30 mg/m2 IV 
−5 Fludarabine 30 mg/m2 IV 
−4 Fludarabine 30 mg/m2 IV 
−3 Melphalan 140 mg/m2 IV; cyclosporine or tacrolimus dosed to maintain appropriate levels through day 100, and then tapered to day 180 
−2 Rest 
−1 Rest 
Bone marrow infusion 
Methotrexate 7.5 mg/m2 IV 
Methotrexate 7.5 mg/m2 IV 
Methotrexate 7.5 mg/m2 IV 
Methylprednisolone 1 mg/kg per day IV through day 28, and then taper granulocyte colony-stimulating factor 5 μg/kg body weight per day IV until absolute neutrophil count is ≥0.5 × 109/L for 3 consecutive days 
DayTreatment
−23 Alemtuzumab test dose 3 mg IV* 
−22 Alemtuzumab 10 mg IV 
−21 Alemtuzumab 15 mg IV 
−20 Alemtuzumab 20 mg IV 
−8 Fludarabine 30 mg/m2 IV 
−7 Fludarabine 30 mg/m2 IV 
−6 Fludarabine 30 mg/m2 IV 
−5 Fludarabine 30 mg/m2 IV 
−4 Fludarabine 30 mg/m2 IV 
−3 Melphalan 140 mg/m2 IV; cyclosporine or tacrolimus dosed to maintain appropriate levels through day 100, and then tapered to day 180 
−2 Rest 
−1 Rest 
Bone marrow infusion 
Methotrexate 7.5 mg/m2 IV 
Methotrexate 7.5 mg/m2 IV 
Methotrexate 7.5 mg/m2 IV 
Methylprednisolone 1 mg/kg per day IV through day 28, and then taper granulocyte colony-stimulating factor 5 μg/kg body weight per day IV until absolute neutrophil count is ≥0.5 × 109/L for 3 consecutive days 
*

The test dose of alemtuzumab was administered 24 hours before the first dose, shown in this example on day −23.

Alemtuzumab treatment was required to be administered on 3 consecutive days but could begin on day −22, −21, or −20 and end on day −20, −19, or −18, respectively.

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