A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
NCT01232556
Last updated date
ABOUT THIS STUDY
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.
Study Location
Disney Family Cancer Center at Providence St Joseph Medical Center
Burbank, California, 91505, United States
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Non-Hodgkin Lymphoma
Sex
Females and Males
Age
18 + years
Inclusion Criteria
Show details
-
Exclusion Criteria
Show details
-
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Non-Hodgkin LymphomaA Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
NCT01232556
- Burbank, California
- Burbank, California
- Fresno, California
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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | |||||||
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Brief Title ICMJE | A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy | ||||||
Official Title ICMJE | 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 | ||||||
Brief Summary | 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Lymphoma, Non-Hodgkin | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE | 338 | ||||||
Original Estimated Enrollment ICMJE | 377 | ||||||
Actual Study Completion Date ICMJE | March 28, 2014 | ||||||
Actual Primary Completion Date | March 28, 2014 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: - Exclusion Criteria: - | ||||||
Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Belgium, Bulgaria, Canada, Croatia, Czechia, France, Germany, Hungary, India, Ireland, Japan, Lithuania, Mexico, Poland, Puerto Rico, Russian Federation, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States | ||||||
Removed Location Countries | Czech Republic, Turkey | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01232556 | ||||||
Other Study ID Numbers ICMJE | B1931008 3129K5-3303 ( Other Identifier: Alias Study Number ) 2010-020147-12 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | UCB Pharma | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | December 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |