Conditions: Lymphoma, Follicular
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 29
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Subjects will receive rituximab intravenously at a dose level of 375 mg/m² on day 1 of each cycle followed by inotuzumab ozogamicin administered intravenously at a dose level of 1.8 mg/m2 on day 2. The sequence will be repeated every 28 days. arm 2: Subjects will receive the investigator's choice from the following rituximab-containing regimens: R-CVP or R-FND. The investigator's choice of therapy will be administered every 21 days. Dosing for R-CVP will be 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, and oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5. Dosing for R-FND will be as follows: rituximab 375 mg/m2 intravenous on day 1, mitoxantrone 10 mg/m2 intravenous on day 2, fludarabine 25 mg/m2 intravenous on days 2 through 4 and oral dexamethasone 20 mg/day on days 1-5.

Interventions: intervention 1: inotuzumab ozogamicin intervention 2: rituximab intervention 3: rituximab intervention 4: cyclophosphamide intervention 5: vincristine intervention 6: prednisone/prednisolone intervention 7: mitoxantrone intervention 8: fludarabine intervention 9: dexamethasone
Intervention descriptions: intervention 1: IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles. intervention 2: IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles. intervention 3: intravenous rituximab at a dose of 375 mg/m2 on day 1 intervention 4: intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1 intervention 5: intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1 intervention 6: oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5 intervention 7: mitoxantrone 10 mg/m2 intravenous on day 2 intervention 8: fludarabine 25 mg/m2 intravenous on days 2 through 4 intervention 9: oral dexamethasone 20 mg/day on days 1-5

Protocol document: