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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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.
4 years
No
Pfizer CT.gov Call Center
Study Director
Pfizer
United States: Food and Drug Administration
3129K4-3301
NCT00562965
November 2007
April 2011
Name | Location |
---|---|
Pfizer Investigational Site | Blendora, California 91740 |
Pfizer Investigational Site | Detroit, Michigan 48201 |
Pfizer Investigational Site | Rochester, Minnesota 55905 |
Pfizer Investigational Site | Bronx, New York 10461 |
Pfizer Investigational Site | Federal Way, Washington 98003 |
Pfizer Investigational Site | Carmel, Indiana 46032 |
Pfizer Investigational Site | Westminster, Maryland 21157 |
Pfizer Investigational Site | Olive Branch, Mississippi 38654 |
Pfizer Investigational Site | Livingston, New Jersey 07039 |