Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)
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.
Drug: inotuzumab ozogamicin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||An Open-Label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin (CMC-544) Administered In Combination With Rituximab Compared To A Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory, CD22-Positive, Follicular B-Cell Non-Hodgkin's Lymphoma|
- To assess efficacy as measured by progression free survival (PFS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- To assess the safety and tolerability of inotuzumab ozogamicin in combination with rituximab. To assess the population pharmacokinetics (PK) of inotuzumab ozogamicin in combination with rituximab, and to evaluate factors affecting drug metabolism. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
- To evaluate the efficacy of inotuzumab ozogamicin in combination with rituximab using the following endpoints and analyses: Overall Response Rate and Overall Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- QT assessment [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
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.
Drug: inotuzumab ozogamicin
IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.Drug: rituximab
IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.
Active Comparator: B
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.
intravenous rituximab at a dose of 375 mg/m2 on day 1Drug: cyclophosphamide
intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1Drug: vincristine
intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1Drug: prednisone/prednisolone
oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5Drug: mitoxantrone
mitoxantrone 10 mg/m2 intravenous on day 2Drug: fludarabine
fludarabine 25 mg/m2 intravenous on days 2 through 4Drug: dexamethasone
oral dexamethasone 20 mg/day on days 1-5
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562965
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|