A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia

PHASE3CompletedINTERVENTIONAL
Enrollment

326

Participants

Timeline

Start Date

August 2, 2012

Primary Completion Date

March 8, 2016

Study Completion Date

January 4, 2017

Conditions
Acute Lymphoblastic Leukemia
Interventions
DRUG

inotuzumab ozogamicin

Dose: inotuzumab ozogamicin 0.8-0.5 mg/m\^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6

DRUG

FLAG (fludarabine, cytarabine and G-CSF)

Dose: cytarabine 2.0 g/m\^2/day IV days 1-6 fludarabine30 mg/m\^2/day IV days 2-6 Cycle length: 28 days Total number of cycles: 4

DRUG

HIDAC (high dose cytarabine)

cytarabine 3 g/m\^2 IV every 12 hours for up to 12 times

DRUG

cytarabine and mitoxantrone

mitoxantrone 12 mg/m\^2 IV days 1-3 cytarabine 200 mg/m\^2/day IV over 7 days cycle length: 15-20 days Total number of cycles: 4

Trial Locations (198)

1097

Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet;, Budapest

3128

Eastern Clinical Research Unit, Box Hill Hospital, Box Hill

4032

Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum II. Belgyogyaszati Klinika, Debrecen

5000

Sanatorio Allende, Córdoba

Royal Adelaide Hospital, Adelaide

10002

National Taiwan University Hospital, Taipei

10021

New York Presbyterian Hospital-Weill Cornell Medical College, New York

10034

Fakultni nemocnice Kralovske Vinohrady, Prague

10065

NewYork-Presbyterian Hospital, New York

Weill Cornell Medical College - New York-Presbyterian Hospital, New York

11030

North Shore University Hospital, Manhasset

11042

Monter Cancer Center, Lake Success

11794

Division of Hematology/Oncology, Stony Brook University Hospital, Stony Brook

Stony Brook University Medical Center, Stony Brook

13009

Institut Paoli-Calmettes, Marseille

14642

University of Rochester Medical Center, Rochester

16132

Clinica Ematologica, Genova

Pharmacy, Genova

Radiology Department (Radiology ONLY), Genova

Radiology Department, Genova

U.O. Ematologia 1, Genova

17033

IDS-investigational drug pharmacy Penn State Milton S. Hershey Medical Center, Hershey

Penn State Milton S. Hershey Medical Center,, Hershey

17176

Hematology Center, Stockholm

20162

S.C. Pharmacy, Milan

S.C. Radiology, Milan

SC Ematologia, Milan

20900

A.O. San Gerardo - Farmacia, Monza

A.O. San Gerardo di Monza, Monza

21000

CHU de Dijon-Hopital d'Enfants-Service d'hematologie Clinique, Dijon

21201

University of Maryland, Baltimore

26506

West Virginia University Hospitals Pharmaceutical Services, Morgantown

West Virginia University Hospitals, Morgantown

27100

Clinica Ematologica, Pavia

27157

Wake Forest Baptist Health, Winston-Salem

27514

UNC Cancer Hospital Infusion Pharmacy, Chapel Hill

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29425

Hollings Cancer Center, Charleston

MUSC Hospital, Charleston

30008

Hospital General Universitario Jose Maria Morales Meseguer, Murcia

30322

Emory University Hospital, Atlanta

Investigational Drug Service, Emory University Clinic, Atlanta

The Emory Clinic, Atlanta

Winship Cancer Institute, Emory University, Atlanta

30342

Blood and Marrow Transplant Group of Georgia, Atlanta

Northside Hospital, Atlanta

30912

Georgia Regents Medical Center Pharmacy, Georgia Regents University Cancer Center, Augusta

Georgia Regents University, Augusta

31059

Iuct - Oncopole, Toulouse

32806

MD Anderson Cancer Center Orlando - 5th Floor Investigational Pharmacy, Orlando

MD Anderson Cancer Center Orlando, Orlando

Orlando Heart Health Institute, Orlando

Orlando Regional Medical Center, Orlando

33100

Clinica Ematologica, Udine

Radiology (Radiology Only), Udine

33155

Miami Children's Hospital, Miami

37007

Hospital Universitario de Salamanca, Salamanca

38043

C.H.U. de Grenoble, Hopital Albert Michallon, Grenoble

40138

Istituto di Ematologia Seragnoli, Bologna

40202

Norton Cancer Institute, Louisville

40207

Norton Cancer Institute, Suburban, Louisville

41013

Hospital Universitario Virgen del Rocio, Seville

42271

Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez

44106

University Hospitals of Cleveland, Cleveland

44124

U.O. di Ematologia Dip. Medicine Specialistiche A.O.U. Arcispedale Sant'Anna, Cona, Ferrara

44195

Cleveland Clinic Foundation, Cleveland

45219

University of Cincinnati Medical Center, Cincinnati

46010

Hospital Clinico Universitario de Valencia, Valencia

47014

IRST-Ematologia, Meldola (FC)

48109

University of Michigan Health System-, Ann Arbor

48121

Radiologist Department, Ravenna

Servizio di Farmacia, Ravenna

U.O. Ematologia, Ospedale S. Maria delle Croci, Ravenna

48149

Zentralapotheke des Universitaetsklinikums Muenster, Münster

Institut fuer klinische Radiologie, Münster

Universitaetsklinikum Muenster, Münster

48201

Karmanos Cancer Institute, Detroit

48334

Karmanos Cancer Institute Weisberg Cancer Treatment Center, Farmington Hills

50005

Fakultni Nemocnice Hradec Kralove, Hradec Králové

50937

Universitätsklinikum Köln, Klinik I für Innere Medizin, Cologne

52242

University of Iowa Hospitals and Clinics, Iowa City

54511

CHU Brabois- Service d'hematologie, Vandœuvre-lès-Nancy

60590

Klinikum der Goethe Universitaet, Frankfurt

60611

Northwestern Medical Faculty Foundation, Chicago

Northwestern Medicine Developmental Therapeutics Institute, Chicago

Northwestern Memorial Hospital, Chicago

60637

The University of Chicago, Chicago

University of Chicago Medical Center, Dept. of Pharmacy, Chicago

62500

Interni Hematologicka a Onkologicka Klinika, Brno

66160

University of Kansas Hospital, Kansas City

66205

University of Kansas Cancer Center, Westwood

69120

Universitaetsklinikum Heidelberg, Heidelberg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

73104

OU Medical Center Presbyterian Tower, Oklahoma City

Stephenson Cancer Center, Oklahoma City

75235

Parkland Health and Hospital System, Dallas

75246

Baylor Charles A. Sammons Cancer Center, Dallas

Baylor University Medical Center, Dallas

75390

University of Texas Southwestern Universtiy Hospital - William P Clements Jr., Dallas

UT Southwestern Medical Center at Dallas, Dallas

UT Southwestern University Hospital- Zale Lipshy, Dallas

75475

Hôpital Saint-Louis, Paris

77030

The University of Texas MD Anderson Cancer Center, Houston

78157

Hopital Universitaire Andre Mignot, Le Chesnay

80045

University of Colorado Cancer Center, Aurora

University of Colorado Hospital, Cancer Center Infusion Center, Aurora

University of Colorado Hospital, Aurora

80131

"AORN A. Cardarelli", Napoli

RAdiology Department (RAdiology only), Napoli

81675

Klinikum Rechts der Isar der TU München, München

83301

Chang Gung Medical Foundation, Kaohsiung Branch, Kaohsiung City

84143

LDS Hospital, Salt Lake City

87042

CHU Dupuytren, Limoges

87131

UNM Cancer Center, Albuquerque

90027

Children's Center for Cancer and Blood Diseases, Childrens Hospital Los Angeles, Los Angeles

90033

Keck Hospital of USC, Los Angeles

LAC+USC Medical Center, Los Angeles

USC Norris Comprehensive Cancer Center, Los Angeles

USC/Norris Comprehensive Cancer Center / Investigational Drug Services, Los Angeles

USC/Norris Comprehensive Cancer Center, Los Angeles

90095

UCLA Drug Information/Investigation Drug, Los Angeles

UCLA Hematology/Oncology Clinic, Los Angeles

UCLA Ronald Reagan Medical Center, Los Angeles

UCLA Rrmc, Los Angeles

92037

UC San Diego Medical Center - La Jolla, La Jolla

92103

UC San Diego Medical Center - Hillcrest, San Diego

92868

Children's Hospital of Orange County, Orange

UC Irvine Medical Center, Orange

93510

Oddzial Hematologii, Klinika Hematologii, Regionalny Osrodek Onkologiczny Wojewodzki Szpital, Lodz

94304

Freidenrich Center for Translational Research (CTRU), Stanford University, Palo Alto

94305

Martha Hamilton, Investigational Drug Services, Dept of Pharmacy, Stanford

Stanford Cancer Institute, Stanford

Stanford University Hospital and Clinics, Stanford

95124

A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto, Catania

Radiology (Radiology Only), Catania

98109

Seattle Cancer Care Alliance, Seattle

98195

University of Washington, Seattle

100020

Beijing Chao-yang Hospital, Beijing

100044

Peking University People's Hospital, Beijing

100071

The 307th Hospital of PLA, Beijing

119228

National University Hospital/National University Cancer Institute Singapore (NCIS), Singapore

130021

The first hospital of jilin university, Changchun

169608

Singapore General Hospital, Singapore

300020

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences,, Tianjin

450008

Henan Cancer Hostipal, Zhengzhou

510080

Guangdong General Hospital, Guangzhou

1040045

National Cancer Center Hospital, Chuo-ku

4668650

Nagoya Daini Red Cross Hospital, Nagoya

5458586

Osaka City University Hospital, Osaka

6638501

The Hospital of Hyogo College of Medicine, Nishinomiya-shi

8111395

National Hospital Organization Kyushu Cancer Center, Fukuoka

9808574

Tohoku University Hospital, Sendai

92037-0845

Investigational Drug Services - UC San Diego Moores Cancer Center, La Jolla

92093-0698

UC San Diego Moores Cancer Center, La Jolla

92868-3201

UC Irvine Medical Center, Orange

06510

Yale-New Haven Hospital & Smilow Cancer Center, New Haven

21231-2410

Oncology Investigational Drug Service, Baltimore

The Sidney Kimmel Comprehensive Cancer Center, Baltimore

02114

Massachusetts General Hospital (MGH), Boston

02115

Brigham and Women's Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

87131-0001

University of New Mexico Comprehensive Cancer Center, Albuquerque

11794-7007

Stony Brook University Medical Center, Stony Brook

11794-9447

Stony Brook University Medical Center, The Cancer Center, Stony Brook

27599-7600

UNC Hospitals - The University of North Carolina at Chapel Hill, Chapel Hill

M5G 2M9

Princess Margaret Cancer Centre, Toronto

00290

HUS-Kuvantaminen, Helsinki

HYKS/Hematologian klinikka, Helsinki

09121

Azienda Ospedaliera Brotzu CTMO P.O. Businco, Cagliari

Farmacia, Cagliari

U.O. Radiodiagnostica, Cagliari

010-8543

Akita University Hospital, Akita

259-1193

Tokai University Hospital, Kanagawa

3015 CE

Erasmus Medical Center, Rotterdam

3075 EA

Erasmus Medical Center, Rotterdam

80-952

Klinika Hematologii i Transplantologii, Gdansk

02-776

Instytut Hematologii i Transfuzjologii, Klinika Hematologii, Warsaw

53-439

Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku, Wroclaw

519-763

Chonnam National University, Hwasun Hospital, Hwasun-Gun

05505

Asan Medical Center, Seoul

135 710

Samsung Medical Center, Seoul

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08035

Hospital Vall d'Hebron, Barcelona

07198

Hospital Son Llatzer, Palma de Mallorca

08025

Hospital de la Santa Creu i Sant Pau(Nuevo Hospital), Barcelona

221 85

Universitetssjukhus Lund, Hematologkliniken, Lund

SO16 6YD

Southampton General Hospital, Southampton

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

HU16 5JQ

Castle Hill Hospital, Hull

NW3 2QG

Department of Academic Oncology, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

NG5 1PB

Nottingham University Hospitals NHS Trust, Nottingham

OX3 7LJ

Churchill Hospital, Oxford

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

UCB Pharma

INDUSTRY

lead

Pfizer

INDUSTRY

NCT01564784 - A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter