A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
Public ClinicalTrials.gov record NCT01232556. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01232556
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 338 participants
Conditions and interventions
Conditions
Interventions
- Inotuzumab ozogamicin Drug
- Rituximab Drug
- rituximab + gemcitabine Drug
- rituximab +bendamustine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 4, 2011 (Actual)
- Primary completion
- Mar 28, 2014 (Actual)
- Completion
- Mar 28, 2014 (Actual)
- Last update posted
- Jan 8, 2019
2011 – 2014
United States locations
- U.S. sites
- 82
- U.S. states
- 21
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Disney Family Cancer Center at Providence St Joseph Medical Center | Burbank | California | 91505 | — |
| Providence St Joseph Medical Center | Burbank | California | 91505 | — |
| Hematology-Oncology Medical Group of Fresno Inc | Fresno | California | 93720 | — |
| Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services | Los Angeles | California | 90095-6981 | — |
| Clinical Research Unit | Los Angeles | California | 90095 | — |
| Peter Morton Medical Plaza | Los Angeles | California | 90095 | — |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | — |
| Sansum Clinic | Santa Barbara | California | 93105 | — |
| UCLA Santa Monica Hematology Oncology | Santa Monica | California | 90404 | — |
| Sansum Clinic | Solvang | California | 93463 | — |
| Howard University Hospital | Washington D.C. | District of Columbia | 20060 | — |
| Mount Sinai Comprehensive Cancer Center at Aventura | Aventura | Florida | 33180 | — |
| University Cancer Institute | Boynton Beach | Florida | 33426 | — |
| 21st Century Oncology of Jacksonville, LLC | Fernandina Beach | Florida | 32034 | — |
| Davis Cancer Pavilion and Shands Medical Plaza | Gainesville | Florida | 32608 | — |
| Shands Cancer Hospital at the University of Florida | Gainesville | Florida | 32608 | — |
| UF Health Davis Cancer Pavillion and Shands Med Plaza | Gainesville | Florida | 32608 | — |
| UF Health Shands Cancer Hospital | Gainesville | Florida | 32608 | — |
| Shands Hospital at the University of Florida | Gainesville | Florida | 32610 | — |
| UF Health Shands Hospital | Gainesville | Florida | 32610 | — |
| 21st Century Oncology of Jacksonville, LLC | Jacksonville | Florida | 32205 | — |
| 21st Century Oncology of Jacksonville, LLC | Jacksonville | Florida | 32207 | — |
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | — |
| Baptist Medical Center | Jacksonville | Florida | 32207 | — |
| 21st Century Oncology of Jacksonville, LLC | Jacksonville | Florida | 32256 | — |
| 21st Century Oncology of Jacksonville, Inc. | Jacksonville | Florida | 32258 | — |
| Medical Specialists Of The Palm Beaches | Lake Worth | Florida | 33467 | — |
| Advanced Medical Specialties | Miami | Florida | 33133 | — |
| Mercy Hospital | Miami | Florida | 33133 | — |
| Mercy Research Institute | Miami | Florida | 33133 | — |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | — |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| 21st Century Oncology of Jacksonville, LLC | Orange Park | Florida | 32073 | — |
| Georgia Regents Medical Cancer Pharmacy | Augusta | Georgia | 30912 | — |
| Georgia Regents University | Augusta | Georgia | 30912 | — |
| Kootenai Cancer Center | Coeur d'Alene | Idaho | 83814 | — |
| Kootenai Cancer Center | Post Falls | Idaho | 083854 | — |
| Decatur Memorial Hospital (DMH) | Decatur | Illinois | 62526 | — |
| Floyd Memorial Cancer Center of Indiana | New Albany | Indiana | 47150 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Kansas Cancer Center and Medical Pavilion | Westwood | Kansas | 66205 | — |
| University of Kentucky A.B. Chandler Medical Center | Lexington | Kentucky | 40536 | — |
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Tulane University Hospital and Clinic | New Orleans | Louisiana | 70112 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Barbara Ann Karmanos Cancer Institute at farmington Hills | Farmington Hills | Michigan | 48334 | — |
| Park Nicollet Frauenshuh Cancer Center | Saint Louis Park | Minnesota | 55426 | — |
| Barnes-Jewish St. Peters | City of Saint Peters | Missouri | 63376 | — |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | — |
| Washington University in St Louis | St Louis | Missouri | 63110 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center | Lincoln | Nebraska | 68510 | — |
| Beth Israel Medical Center; | New York | New York | 10003 | — |
| Beth Israel Comprehensive Cancer Center | New York | New York | 10011-5903 | — |
| St Luke's- Roosevelt Hospital Center | New York | New York | 10019 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Stony Brook University Medical Center, The Cancer Center | Stony Brook | New York | 11794 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| University Hospital | Cincinnati | Ohio | 45219 | — |
| West Chester Hospital Medical Building | West Chester | Ohio | 45069 | — |
| OU Medical Center Presbyterian Professional Building | Oklahoma City | Oklahoma | 73104 | — |
| OU Medical Center Presbyterian Tower | Oklahoma City | Oklahoma | 73104 | — |
| Peggy and Charles Stephenson Cancer Center (chemo & infusion) | Oklahoma City | Oklahoma | 73104 | — |
| Peggy and Charles Stephenson Cancer Center (clinic location) | Oklahoma City | Oklahoma | 73104 | — |
| Good Samaritan Hospital Corvallis | Corvallis | Oregon | 97330 | — |
| Good Samaritan Hospital, Corvallis | Corvallis | Oregon | 97330 | — |
| Samaritan Ambulatory Infusion Services | Corvallis | Oregon | 97330 | — |
| Samaritan Pacific Coast Hospital | Newport | Oregon | 97365 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Guthrie Clinic, Ltd. | Sayre | Pennsylvania | 18840 | — |
| Robert Packer Hospital | Sayre | Pennsylvania | 18840 | — |
| Thompson Oncology Group | Knoxville | Tennessee | 37916 | — |
| Thompson Oncology Group | Knoxville | Tennessee | 37932 | — |
| Thompson Oncology Group | Maryville | Tennessee | 37804 | — |
| Thompson Oncology Group | Sevierville | Tennessee | 37862 | — |
| University Hospital - St. Paul | Dallas | Texas | 75235 | — |
| University Hospital - Zale Lipshy | Dallas | Texas | 75235 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| Baylor: Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 95 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01232556, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 8, 2019 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01232556 live on ClinicalTrials.gov.