AN OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN ADMINISTERED IN COMBINATION WITH RITUXIMAB COMPARED TO DEFINED INVESTIGATOR'S CHOICE THERAPY IN SUBJECTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE AGGRESSIVE NON-HODGKIN LYMPHOMA WHO ARE NOT CANDIDATES FOR INTENSIVE HIGH-DOSE CHEMOTHERAPY
AN OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN ADMINISTERED IN COMBINATION WITH RITUXIMAB COMPARED TO DEFINED INVESTIGATOR'S CHOICE THERAPY IN SUBJECTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE AGGRESSIVE NON-HODGKIN LYMPHOMA WHO ARE NOT CANDIDATES FOR INTENSIVE HIGH-DOSE CHEMOTHERAPY
The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.
Inclusion Criteria:
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Exclusion Criteria:
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Burbank, California 91505, United States
Los Angeles, California 90095-6981, United States
Farmington Hills, Michigan 48334, United States
Lincoln, Nebraska 68510, United States
Oklahoma City, Oklahoma 73104, United States
Oklahoma City, Oklahoma 73104, United States
Sofia, 1756, Bulgaria
Sherbrooke, Quebec J1H 5N4, Canada
Zagreb, 10010, Croatia
Debrechen, 4032, Hungary
Toon-shi, Ehime 791-0295, Japan
Sunto-gun, Shizuoka 411-8777, Japan
Chuo-ku, Tokyo 104-0045, Japan
Koto-Ku, Tokyo 135-8550, Japan
Moscow, 125167, Russia
Saint Petersburg, 197022, Russia
Kuei-Shan Hsiang, Taoyuan County 333, Taiwan
Bangkoknoi, Bangkok 10700, Thailand
London, EC1A 7BE, United Kingdom
Newcastle upon Tyne, NE1 4LP, United Kingdom
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham, NG5 1PB, United Kingdom
Nottingham, NG51PB, United Kingdom