This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.
On January 14th 2009, enrollment in the study was discontinued because of poor enrollment and because it was unlikely that the study would meet the estimated enrollment of approximately 978 subjects. The decision was not prompted by the identification of any safety signals in this or other studies. Active treatment and follow-up of the already enrolled subjects was continued. On July, 22th 2010 , the study was amended to shorten the long-term follow-up to one year after active treatment.
IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.
IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.
intravenous rituximab at a dose of 375 mg/m2 on day 1
intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1
intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1
oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5
mitoxantrone 10 mg/m2 intravenous on day 2
fludarabine 25 mg/m2 intravenous on days 2 through 4
oral dexamethasone 20 mg/day on days 1-5
Rosario, Santa Fe Province, Argentina