A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
Stopped early · Phase 3
Conditions studied: Lymphoma, Non-Hodgkin
In brief
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.
Key facts
- Study ID
- NCT01232556
- Run by
- Pfizer
- People needed
- 338
- Starts
- 2011-04-04
- Expected to finish
- 2014-03-28
- Last updated by the study team
- 2019-01-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Providence St Joseph Medical Center — Burbank, California, United States
- Hematology-Oncology Medical Group of Fresno Inc — Fresno, California, United States
- Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services — Los Angeles, California, United States
- Clinical Research Unit — Los Angeles, California, United States
- Peter Morton Medical Plaza — Los Angeles, California, United States
- Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
- Sansum Clinic — Santa Barbara, California, United States
- UCLA Santa Monica Hematology Oncology — Santa Monica, California, United States
- Sansum Clinic — Solvang, California, United States
- Howard University Hospital — Washington D.C., District of Columbia, United States
- Mount Sinai Comprehensive Cancer Center at Aventura — Aventura, Florida, United States
- University Cancer Institute — Boynton Beach, Florida, United States
- 21st Century Oncology of Jacksonville, LLC — Fernandina Beach, Florida, United States
- Davis Cancer Pavilion and Shands Medical Plaza — Gainesville, Florida, United States
- Shands Cancer Hospital at the University of Florida — Gainesville, Florida, United States
- UF Health Davis Cancer Pavillion and Shands Med Plaza — Gainesville, Florida, United States
- UF Health Shands Cancer Hospital — Gainesville, Florida, United States
- Shands Hospital at the University of Florida — Gainesville, Florida, United States
- UF Health Shands Hospital — Gainesville, Florida, United States
- 21st Century Oncology of Jacksonville, LLC — Jacksonville, Florida, United States
- 21st Century Oncology of Jacksonville, LLC — Jacksonville, Florida, United States
- Baptist Cancer Institute — Jacksonville, Florida, United States
- Baptist Medical Center — Jacksonville, Florida, United States
- 21st Century Oncology of Jacksonville, LLC — Jacksonville, Florida, United States
- Disney Family Cancer Center at Providence St Joseph Medical Center — Burbank, California, United States
Full record on ClinicalTrials.gov
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