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Brief Title: A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
Official Title: AN OPEN-LABEL, RANDOMIZED PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN COMPARED TO A DEFINED INVESTIGATOR'S CHOICE IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)
Study ID: NCT01564784
Brief Summary: This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Investigational Drug Services - UC San Diego Moores Cancer Center, La Jolla, California, United States
UC San Diego Medical Center - La Jolla, La Jolla, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Children's Center for Cancer and Blood Diseases, Childrens Hospital Los Angeles, Los Angeles, California, United States
Keck Hospital of USC, Los Angeles, California, United States
LAC+USC Medical Center, Los Angeles, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center / Investigational Drug Services, Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCLA Drug Information/Investigation Drug, Los Angeles, California, United States
UCLA Hematology/Oncology Clinic, Los Angeles, California, United States
UCLA Ronald Reagan Medical Center, Los Angeles, California, United States
UCLA Rrmc, Los Angeles, California, United States
UC Irvine Medical Center, Orange, California, United States
Children's Hospital of Orange County, Orange, California, United States
UC Irvine Medical Center, Orange, California, United States
Freidenrich Center for Translational Research (CTRU), Stanford University, Palo Alto, California, United States
UC San Diego Medical Center - Hillcrest, San Diego, California, United States
Martha Hamilton, Investigational Drug Services, Dept of Pharmacy, Stanford, California, United States
Stanford Cancer Institute, Stanford, California, United States
Stanford University Hospital and Clinics, Stanford, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
University of Colorado Hospital, Cancer Center Infusion Center, Aurora, Colorado, United States
University of Colorado Hospital, Aurora, Colorado, United States
Yale-New Haven Hospital & Smilow Cancer Center, New Haven, Connecticut, United States
Miami Children's Hospital, Miami, Florida, United States
MD Anderson Cancer Center Orlando - 5th Floor Investigational Pharmacy, Orlando, Florida, United States
MD Anderson Cancer Center Orlando, Orlando, Florida, United States
Orlando Heart Health Institute, Orlando, Florida, United States
Orlando Regional Medical Center, Orlando, Florida, United States
Emory University Hospital, Atlanta, Georgia, United States
Investigational Drug Service, Emory University Clinic, Atlanta, Georgia, United States
The Emory Clinic, Atlanta, Georgia, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
Northside Hospital, Atlanta, Georgia, United States
Georgia Regents Medical Center Pharmacy, Georgia Regents University Cancer Center, Augusta, Georgia, United States
Georgia Regents University, Augusta, Georgia, United States
Northwestern Medical Faculty Foundation, Chicago, Illinois, United States
Northwestern Medicine Developmental Therapeutics Institute, Chicago, Illinois, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
The University of Chicago, Chicago, Illinois, United States
University of Chicago Medical Center, Dept. of Pharmacy, Chicago, Illinois, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Kansas Hospital, Kansas City, Kansas, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Norton Cancer Institute, Suburban, Louisville, Kentucky, United States
University of Maryland, Baltimore, Maryland, United States
Oncology Investigational Drug Service, Baltimore, Maryland, United States
The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital (MGH), Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Health System-, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, United States
UNM Cancer Center, Albuquerque, New Mexico, United States
Monter Cancer Center, Lake Success, New York, United States
North Shore University Hospital, Manhasset, New York, United States
New York Presbyterian Hospital-Weill Cornell Medical College, New York, New York, United States
NewYork-Presbyterian Hospital, New York, New York, United States
Weill Cornell Medical College - New York-Presbyterian Hospital, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Stony Brook University Medical Center, The Cancer Center, Stony Brook, New York, United States
Division of Hematology/Oncology, Stony Brook University Hospital, Stony Brook, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
UNC Cancer Hospital Infusion Pharmacy, Chapel Hill, North Carolina, United States
UNC Hospitals - The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
University Hospitals of Cleveland, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
OU Medical Center Presbyterian Tower, Oklahoma City, Oklahoma, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
IDS-investigational drug pharmacy Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center,, Hershey, Pennsylvania, United States
Hollings Cancer Center, Charleston, South Carolina, United States
MUSC Hospital, Charleston, South Carolina, United States
Parkland Health and Hospital System, Dallas, Texas, United States
Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Baylor University Medical Center, Dallas, Texas, United States
University of Texas Southwestern Universtiy Hospital - William P Clements Jr., Dallas, Texas, United States
UT Southwestern Medical Center at Dallas, Dallas, Texas, United States
UT Southwestern University Hospital- Zale Lipshy, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
LDS Hospital, Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Washington, Seattle, Washington, United States
West Virginia University Hospitals Pharmaceutical Services, Morgantown, West Virginia, United States
West Virginia University Hospitals, Morgantown, West Virginia, United States
Sanatorio Allende, Cordoba, , Argentina
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Eastern Clinical Research Unit, Box Hill Hospital, Box Hill, Victoria, Australia
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Guangdong General Hospital, Guangzhou, Guangdong, China
Henan Cancer Hostipal, Zhengzhou, Henan, China
The first hospital of jilin university, Changchun, Jilin, China
Beijing Chao-yang Hospital, Beijing, , China
Peking University People's Hospital, Beijing, , China
The 307th Hospital of PLA, Beijing, , China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences,, Tianjin, , China
Interni Hematologicka a Onkologicka Klinika, Brno, , Czechia
Fakultni Nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha 10, , Czechia
HUS-Kuvantaminen, Helsinki, , Finland
HYKS/Hematologian klinikka, Helsinki, , Finland
CHU de Dijon-Hopital d'Enfants-Service d'hematologie Clinique, Dijon, , France
C.H.U. de Grenoble, Hopital Albert Michallon, Grenoble Cedex 09, , France
Hopital Universitaire Andre Mignot, Le Chesnay Cedex, , France
CHU Dupuytren, Limoges Cedex, , France
Institut Paoli-Calmettes, Marseille, , France
Hôpital Saint-Louis, Paris Cedex 10, , France
Centre Hospitalier Lyon Sud, Pierre Benite Cedex, , France
Institut de Cancérologie Lucien Neuwirth, Saint Priest en Jarez Cedex, , France
Iuct - Oncopole, Toulouse Cedex 9, , France
CHU Brabois- Service d'hematologie, Vandoeuvre-les-Nancy, , France
Zentralapotheke des Universitaetsklinikums Muenster, Muenster, Nordrhein-westfalen, Germany
Klinikum der Goethe Universitaet, Frankfurt, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Universitätsklinikum Köln, Klinik I für Innere Medizin, Köln, , Germany
Klinikum Rechts der Isar der TU München, Muenchen, , Germany
Institut fuer klinische Radiologie, Muenster, , Germany
Universitaetsklinikum Muenster, Muenster, , Germany
Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet;, Budapest, , Hungary
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum II. Belgyogyaszati Klinika, Debrecen, , Hungary
Azienda Ospedaliera Brotzu CTMO P.O. Businco, Cagliari, CA, Italy
Farmacia, Cagliari, CA, Italy
U.O. Radiodiagnostica, Cagliari, CA, Italy
IRST-Ematologia, Meldola (FC), FC, Italy
Istituto di Ematologia Seragnoli, Bologna, , Italy
A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto, Catania, , Italy
Radiology (Radiology Only), Catania, , Italy
U.O. di Ematologia Dip. Medicine Specialistiche A.O.U. Arcispedale Sant'Anna, Cona, Ferrara, , Italy
Clinica Ematologica, Genova, , Italy
Pharmacy, Genova, , Italy
Radiology Department (Radiology ONLY), Genova, , Italy
Radiology Department, Genova, , Italy
U.O. Ematologia 1, Genova, , Italy
S.C. Pharmacy, Milano, , Italy
S.C. Radiology, Milano, , Italy
SC Ematologia, Milano, , Italy
A.O. San Gerardo - Farmacia, Monza, , Italy
A.O. San Gerardo di Monza, Monza, , Italy
AORN "A. Cardarelli", Napoli, , Italy
RAdiology Department (RAdiology only), Napoli, , Italy
Clinica Ematologica, Pavia, , Italy
Radiologist Department, Ravenna, , Italy
Servizio di Farmacia, Ravenna, , Italy
U.O. Ematologia, Ospedale S. Maria delle Croci, Ravenna, , Italy
Clinica Ematologica, Udine, , Italy
Radiology (Radiology Only), Udine, , Italy
Nagoya Daini Red Cross Hospital, Nagoya, Aichi, Japan
The Hospital of Hyogo College of Medicine, Nishinomiya-shi, Hyogo, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
Osaka City University Hospital, Osaka-city, Osaka, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Akita University Hospital, Akita, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Tokai University Hospital, Kanagawa, , Japan
Chonnam National University, Hwasun Hospital, Hwasun-Gun, Jeonnam, Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Erasmus Medical Center, Rotterdam, South Holland, Netherlands
Erasmus Medical Center, Rotterdam, South Holland, Netherlands
Klinika Hematologii i Transplantologii, Gdansk, , Poland
Oddzial Hematologii, Klinika Hematologii, Regionalny Osrodek Onkologiczny Wojewodzki Szpital, Lodz, , Poland
Instytut Hematologii i Transfuzjologii, Klinika Hematologii, Warsaw, , Poland
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku, Wroclaw, , Poland
National University Hospital/National University Cancer Institute Singapore (NCIS), Singapore, , Singapore
Singapore General Hospital, Singapore, , Singapore
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Universitario de Salamanca, Salamanca, Castille AND LION, Spain
Hospital Vall d'Hebron, Barcelona, Catalonia, Spain
Hospital Son Llatzer, Palma de Mallorca, Mallorca, Spain
Hospital de la Santa Creu i Sant Pau(Nuevo Hospital), Barcelona, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital General Universitario Jose Maria Morales Meseguer, Murcia, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Universitetssjukhus Lund, Hematologkliniken, Lund, , Sweden
Hematology Center, Stockholm, , Sweden
Chang Gung Medical Foundation, Kaohsiung Branch, Kaohsiung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Southampton General Hospital, Southampton, Hampshire, United Kingdom
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Castle Hill Hospital, Hull, , United Kingdom
Department of Academic Oncology, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR