Study Stopped
The study was terminated prematurely on May 16, 2013, for futility. No new or unexpected safety issues were identified.
A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients 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
3 other identifiers
interventional
338
25 countries
177
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2011
Typical duration for phase_3
177 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedStudy Start
First participant enrolled
April 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2014
CompletedResults Posted
Study results publicly available
August 21, 2018
CompletedJanuary 8, 2019
December 1, 2018
3 years
October 27, 2010
July 17, 2017
December 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival
Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. The Kaplan-Meier method was used to determine OS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.
From randomization up to 5 years after last dose or up to final study visit, whichever occurs first.
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)
Includes all TEAEs: Any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration..
Up to 20 weeks after the first dose of study drug
Secondary Outcomes (6)
Progression-Free Survival (PFS)
From randomization up to 2 years or final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL
Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL
Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
Duration of Response
Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
Health Status as Assessed by the European Quality of Life 5 Dimension (EQ-5D) Questionnaire
Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALInotuzumab ozogamicin+rituximab
2
ACTIVE COMPARATORInvestigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine
Interventions
1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles
rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 to 6, every 28 days by IV infusion, 3 to 6 cycles; gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles
rituximab 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles; bendamustine 120 mg/m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- UCB Pharmacollaborator
Study Sites (177)
Disney Family Cancer Center at Providence St Joseph Medical Center
Burbank, California, 91505, United States
Providence St Joseph Medical Center
Burbank, California, 91505, United States
Hematology-Oncology Medical Group of Fresno Inc
Fresno, California, 93720, United States
Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services
Los Angeles, California, 90095-6981, United States
Clinical Research Unit
Los Angeles, California, 90095, United States
Peter Morton Medical Plaza
Los Angeles, California, 90095, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
UCLA Santa Monica Hematology Oncology
Santa Monica, California, 90404, United States
Sansum Clinic
Solvang, California, 93463, United States
Howard University Hospital
Washington D.C., District of Columbia, 20060, United States
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180, United States
University Cancer Institute
Boynton Beach, Florida, 33426, United States
21st Century Oncology of Jacksonville, LLC
Fernandina Beach, Florida, 32034, United States
Davis Cancer Pavilion and Shands Medical Plaza
Gainesville, Florida, 32608, United States
Shands Cancer Hospital at the University of Florida
Gainesville, Florida, 32608, United States
UF Health Davis Cancer Pavillion and Shands Med Plaza
Gainesville, Florida, 32608, United States
UF Health Shands Cancer Hospital
Gainesville, Florida, 32608, United States
Shands Hospital at the University of Florida
Gainesville, Florida, 32610, United States
UF Health Shands Hospital
Gainesville, Florida, 32610, United States
21st Century Oncology of Jacksonville, LLC
Jacksonville, Florida, 32205, United States
21st Century Oncology of Jacksonville, LLC
Jacksonville, Florida, 32207, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Baptist Medical Center
Jacksonville, Florida, 32207, United States
21st Century Oncology of Jacksonville, LLC
Jacksonville, Florida, 32256, United States
21st Century Oncology of Jacksonville, Inc.
Jacksonville, Florida, 32258, United States
Medical Specialists Of The Palm Beaches
Lake Worth, Florida, 33467, United States
Advanced Medical Specialties
Miami, Florida, 33133, United States
Mercy Hospital
Miami, Florida, 33133, United States
Mercy Research Institute
Miami, Florida, 33133, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
21st Century Oncology of Jacksonville, LLC
Orange Park, Florida, 32073, United States
Georgia Regents Medical Cancer Pharmacy
Augusta, Georgia, 30912, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
Kootenai Cancer Center
Coeur d'Alene, Idaho, 83814, United States
Kootenai Cancer Center
Post Falls, Idaho, 083854, United States
Decatur Memorial Hospital (DMH)
Decatur, Illinois, 62526, United States
Floyd Memorial Cancer Center of Indiana
New Albany, Indiana, 47150, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, 66205, United States
University of Kentucky A.B. Chandler Medical Center
Lexington, Kentucky, 40536, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Barbara Ann Karmanos Cancer Institute at farmington Hills
Farmington Hills, Michigan, 48334, United States
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426, United States
Barnes-Jewish St. Peters
City of Saint Peters, Missouri, 63376, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University in St Louis
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Washington University
St Louis, Missouri, 63110, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510, United States
Beth Israel Medical Center;
New York, New York, 10003, United States
Beth Israel Comprehensive Cancer Center
New York, New York, 10011-5903, United States
St Luke's- Roosevelt Hospital Center
New York, New York, 10019, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Stony Brook University Medical Center, The Cancer Center
Stony Brook, New York, 11794, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
University Hospital
Cincinnati, Ohio, 45219, United States
West Chester Hospital Medical Building
West Chester, Ohio, 45069, United States
OU Medical Center Presbyterian Professional Building
Oklahoma City, Oklahoma, 73104, United States
OU Medical Center Presbyterian Tower
Oklahoma City, Oklahoma, 73104, United States
Peggy and Charles Stephenson Cancer Center (chemo & infusion)
Oklahoma City, Oklahoma, 73104, United States
Peggy and Charles Stephenson Cancer Center (clinic location)
Oklahoma City, Oklahoma, 73104, United States
Good Samaritan Hospital Corvallis
Corvallis, Oregon, 97330, United States
Good Samaritan Hospital, Corvallis
Corvallis, Oregon, 97330, United States
Samaritan Ambulatory Infusion Services
Corvallis, Oregon, 97330, United States
Samaritan Pacific Coast Hospital
Newport, Oregon, 97365, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Guthrie Clinic, Ltd.
Sayre, Pennsylvania, 18840, United States
Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Thompson Oncology Group
Knoxville, Tennessee, 37916, United States
Thompson Oncology Group
Knoxville, Tennessee, 37932, United States
Thompson Oncology Group
Maryville, Tennessee, 37804, United States
Thompson Oncology Group
Sevierville, Tennessee, 37862, United States
University Hospital - St. Paul
Dallas, Texas, 75235, United States
University Hospital - Zale Lipshy
Dallas, Texas, 75235, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Baylor: Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Simmons Comprehensive Cancer Center
Dallas, Texas, 75390, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams Brabant, 3000, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
Grand Hopital de Charleroi
Charleroi, 6000, Belgium
H.-Hartziekenhuis Roeselare-Menen
Roeselare, 8800, Belgium
St Augustinus Ziekenhuis
Wilrijk, 2610, Belgium
Cliniques universitaires UCL de Mont-Godinne,
Yvoir, 5530, Belgium
UMBAL Sveti Georgi, Klinika po hematologia
Plovdiv, 4002, Bulgaria
SBAL na Hematologichnichni Zabolyavania,CTH Sofia
Sofia, 1756, Bulgaria
Spetsializirana Bolnitsa za Aktivno Lechenie na Hematologichni Zabolyavania, CTH Sofia
Sofia, 1756, Bulgaria
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3 M5, Canada
Centre Hospitalier Universitaire de Sherbrooke (CHUS), Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
University Hospital Zagreb
Zagreb, 10000, Croatia
University Hospital Dubrava Department of Internal Medicine Division of Hematology
Zagreb, 10010, Croatia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czech Republic, 100 34, Czechia
Fakultni nemocnice Brno
Brno, 62500, Czechia
Département Pharmacie
Marseille, Bouches-du-rhône, Cedex 09 13273, France
Institut Paoli Calmettes
Marseille, Cedex 09, 13273, France
Hopital Andre Mignot
Le Chesnay, Yvelines, 78157, France
Hospital Universitaire Andre Mignot
Le Chesnay, Yvelines, 78157, France
Centre Leon Berard
Lyon, 69373, France
CHU Saint Eloi
Montpellier, 34295Cedex5, France
Hopital du haut Leveque
Pessac, 33600, France
Centre Henri Becquerel
Rouen, 76038, France
Universitaetsklinikum Aachen
Aachen, 52074, Germany
Sozialstiftung Bamberg
Bamberg, 96049, Germany
Charite Campus Benjamin Franklin
Berlin, 10117, Germany
Charite Campus Virchow-Klinikum
Berlin, 13353, Germany
Universitaetsklinikum Mainz
Mainz, 55101, Germany
TU Muenchen III. Medizinische Klinik
München, 81675, Germany
Universitaetsklinik Ulm
Ulm, 89081, Germany
Egyesitett Szent Istvan es Szent Laszlo Korhaz /
Budapest, 1097, Hungary
DEOEC, Belgyogyaszati Intezet
Debrechen, 4032, Hungary
Somongy Megyei Kaposi Mor Okato Korhaz/ Belgyogyaszati osztaly
Kaposvár, 7400, Hungary
Kodlikeri Memorial Hospital
Aurangabad, Maharashtra, 431 005, India
Sahyadri Clinical Research and Development Center
Pune, Maharashtra, 411 004, India
OEC Record Management Company Pvt. Ltd.,
Pune, Maharashtra, 411004, India
Sahyadri Speciality Hospital
Pune, Maharashtra, 411004, India
Bon Secours Hospital
Cork, Ireland
Nagoya Daini Red Cross Hospital
Nagoya, Aichi-ken, 4668650, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Ehime University Hospital
Toon-shi, Ehime, 791-0295, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Matsushita Memorial Hospital
Moriguchi, Osaka, 570-8540, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Cancer Institute Hospital, Japanese Foundation For Cancer Research
Koto-Ku, Tokyo, 135-8550, Japan
Akita University Hospital
Akita, 010-8543, Japan
National Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Tokai University Hospital
Kanagawa, 259-1193, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Klaipeda Seamen's Hospital, Public Institution, department of Oncology
Klaipėda, 92288, Lithuania
Instituto Biomédico de Investigación A.C.
Aguascalientes, Aguascalientes. Mexico, 20127, Mexico
Niepubliczny Zaklad Opieki Zdrowotnej AVI Diagnostyka Obrazowa
Warsaw, 00-728, Poland
Klinika Nowotworow Ukladu Chlonnego
Warsaw, 02-781, Poland
Advanced Infusion Services
Cataño, 00962, Puerto Rico
Hospital Espanol Auxilio Mutuo de Puerto Rico Inc
San Juan, 00918, Puerto Rico
Federal State Budgetary Institution Hematology Scientific Centre of Ministry of
Moscow, 125167, Russia
Moscow State Healthcare Institution City clinical hospital S.P. Botkin
Moscow, 125284, Russia
Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva
Saint Petersburg, 197022, Russia
National University Hospital
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Narodny onkologicky ustav
Bratislava, 833 10, Slovakia
Hospital Virgen Del Rocio
Seville, Andalusia, 41013, Spain
Hospital Universitario De Salamanca
Salamanca, Castille and LION, 37007, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Clinic Universitari de Barcelona
Barcelona, 08036, Spain
Institut Catala d'Oncologia-L'Hospitalet
L'Hospitalet de Llobregat (bcn), 08907, Spain
Hospital Universitario de Canarias
La Laguna (Tenerife), 38320, Spain
Hospital de la Princesa
Madrid, 28006, Spain
Universitetssjukhuset
Linköping, 58185, Sweden
Skanes Universitetssjukhus i Lund
Lund, 221 85, Sweden
Chang Gung Medical Foundation - Linkou Branch
Kuei-Shan Hsiang, Taoyuan County, 333, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital, Department of Internal Medicine
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Hematology Division Department of Medicine Faculty of Medicine Siriraj Hospital Mahidol University
Bangkoknoi, Bangkok, 10700, Thailand
Chiang Mai University
Chiang Mai, 50200, Thailand
Regional Treatment and Diagnostic Hematology Center Communal Establishment
Cherkasy, 18009, Ukraine
Department of Oncology and Medical Radiology of State Institution
Dnipropetrovsk, 49102, Ukraine
SI"Research Center for Radiation Medicine of NAMS of Ukraine"
Kyiv, 03115, Ukraine
Barts Cancer Centre Dept Haemato-oncology St. Bartholomew's Hospital Barts Health NHS Trust
London, EC1A 7BE, United Kingdom
Chemotherapy Preparative Unit St. Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Department of Medical Oncology St. Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
The Christie NHS Foundation Trust - Christie Hospital
Manchester, M20 4BX, United Kingdom
Department of Clinical Pathology Newcastle upon Tyne Hospitals NHS Foundation Trust Royal Victoria I
Newcastle upon Tyne, NE1 4LP, United Kingdom
Department of Clinical Biochemistry Newcastle upon Tyne Hospitals
Newcastle upon Tyne, NE7 7DN, United Kingdom
Northern Centre for Cancer Care
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham University Hospital
Nottingham, NG5 1PB, United Kingdom
Pathology Department Nottingham University Hospital - City Hospital Campus
Nottingham, NG5 1PB, United Kingdom
Pharmacy Nottingham University Hospital - City Hospital Campus
Nottingham, NG5 1PB, United Kingdom
Local Laboratory Nottingham University Hospital - City Hospital Campus
Nottingham, NG51PB, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Interpretation of the results is limited by the small number of subjects analyzed and follow-up period was shortened due to the early termination of the study. Adverse Events were calculated using the safety populations.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2010
First Posted
November 2, 2010
Study Start
April 4, 2011
Primary Completion
March 28, 2014
Study Completion
March 28, 2014
Last Updated
January 8, 2019
Results First Posted
August 21, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.