Trial record 1 of 1 for:    B1931022
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A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01564784
First received: March 26, 2012
Last updated: July 8, 2016
Last verified: July 2016
  Purpose
This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.

Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: inotuzumab ozogamicin
Drug: FLAG (fludarabine, cytarabine and G-CSF)
Drug: HIDAC (high dose cytarabine)
Drug: cytarabine and mitoxantrone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Response to therapy (percentage of patients achieving a complete response and complete response with incomplete platelet and/or neutrophil recovery). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • Volume of distribution (Vd) for inotuzumab ozogamicin in serum [ Time Frame: Cycle 1, Days 1, 3, 8 and 15; Cycle 2 , Days 1 and 8; Cycle 4, Days 1 and 8 ] [ Designated as safety issue: No ]
  • Systemic clearance (CL) for inotuzumab ozogamicin in serum [ Time Frame: Cycle 1, Days 1, 3, 8 and 15; Cycle 2 , Days 1 and 8; Cycle 4, Days 1 and 8 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • Rate of stem-cell transplantation: percentage of patients having stem-cell transplant [ Time Frame: Baseline to 8 months ] [ Designated as safety issue: No ]
  • Minimal residual disease (MRD): number of leukemic cells in bone marrow after CR/CRi [ Time Frame: Baseline to 7 months ] [ Designated as safety issue: No ]
  • Cytogenetics: quantitate t(9;22), MLL, and IGH rearrangements in leukemia cells [ Time Frame: Baseline to 7 months ] [ Designated as safety issue: No ]
  • Quality of life: . EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer. Quality of Life Questionnaire, Core-30 [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  • Quality of life: EQ-5D = EuroQual -5D Health Questionnaire [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 325
Study Start Date: August 2012
Estimated Study Completion Date: August 2017
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A 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
Active Comparator: Arm B 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CD22 expression
  • Adequate liver and renal functions

Exclusion Criteria:

  • Isolated extramedullary disease
  • Active Central Nervous System [CNS] disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564784

  Hide Study Locations
Locations
United States, California
UC San Diego Medical Center - La Jolla
La Jolla, California, United States, 92037
Investigational Drug Services - UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037-0845
UC San Diego Moores Cancer Center
LaJolla, California, United States, 92093-0698
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
Children's Center for Cancer and Blood Diseases, Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Keck Hospital of USC
Los Angeles, California, United States, 90033
USC/Norris Comprehensive Cancer Center / Investigational Drug Services
Los Angeles, California, United States, 90033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
UCLA Hematology/Oncology Clinic
Los Angeles, California, United States, 90095
Lac & Usc Medical Center
Los Angeles, California, United States, 90033
Children's Hospital of Orange County
Orange, California, United States, 92868
UC Irvine Medical Center
Orange, California, United States, 92868
Stanford University Cancer Clinical Trials Office
Palo Alto, California, United States, 94304
Stanford University Hospital and Clinics - Clinical Translation Research Unit
Palo Alto, California, United States, 94304
UC San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103
Stanford University Hospital and Clinics
Stanford, California, United States, 94305
Stanford Cancer Institute
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
University of Colorado Hospital, Cancer Center Infusion Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Smilow Cancer Center at Yale New Haven Hospital (Drug Shipment Address)
New Haven, Connecticut, United States, 06510
Yale-New Haven Hospital & Smilow Cancer Center
New Haven, Connecticut, United States, 06510
United States, Florida
Miami Children's Hospital
Miami, Florida, United States, 33155
MD Anderson Cancer Center Orlando - 5th Floor Investigational Pharmacy
Orlando, Florida, United States, 32806
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Orlando Heart Health Institute
Orlando, Florida, United States, 32806
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
United States, Georgia
Emory University Clinic - Investigational Drug Service
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
The Emory Clinic
Atlanta, Georgia, United States, 30322
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
Northside Hospital
Atlanta, Georgia, United States, 30342
Georgia Regents Medical Center Pharmacy, Georgia Regents University Cancer Center
Augusta, Georgia, United States, 30912
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Northwestern Memorial Hospital - Drug Shipment Address
Chicago, Illinois, United States, 60611
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Northwestern Medical Faculty Foundation (NMFF)
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
United States, Kentucky
Norton Cancer Institute, Suburban
Louisville, Kentucky, United States, 40207
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Maryland
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Health System-
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Famington Hills, Michigan, United States, 48334
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
UNM Cancer Center IP Only
Albuquerque, New Mexico, United States, 87131
United States, New York
Monter Cancer Center
Lake Success, New York, United States, 11042
North Shore University Hospital
Manhasset, New York, United States, 11030
New York Presbyterian Hospital - Weill Cornell Medical College
New York, New York, United States, 10065
New York Presbyterian Hospital - Weill Cornell Medical College
New York, New York, United States, 10021
University of Rochester Medical Center
Rochester, New York, United States, 14642
Ship drug to: University of Rochester
Rochester, New York, United States, 14642
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794-7007
Stony Brook University Medical Center, The Cancer Center
Stony Brook, New York, United States, 11794-9447
Divison of Hematology/Oncology, Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
United States, North Carolina
UNC Cancer Hospital Infusion Pharmacy
Chapel Hill, North Carolina, United States, 27514
UNC Hospitals - The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7600
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oklahoma
OU Medical Center Presbyterian Tower
Oklahoma City, Oklahoma, United States, 73104
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center,
Hershey, Pennsylvania, United States, 17033-0850
United States, South Carolina
Hollings Cancer Center
Charleston, South Carolina, United States, 29425
United States, Texas
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Parkland Health and Hospital System
Dallas, Texas, United States, 75235
Baylor University Medical Center
Dallas, Texas, United States, 75246
UT Southwestern Medical Center: Simmons Pharmacy
Dallas, Texas, United States, 75390-9015
Harold C. Simmons Comprehensive Cancer Center-University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
University of Texas Southwestern Universtiy Hospital - William P Clements Jr.
Dallas, Texas, United States, 75390
UT Southwestern University Hospital- Zale Lipshy
Dallas, Texas, United States, 75390
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington
Seattle, Washington, United States, 98195
United States, West Virginia
West Virginia University Hospitals Pharmaceutical Services
Morgantown, West Virginia, United States, 26506
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
Argentina
Sanatorio Allende
Cordoba, Argentina, 5000
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Eastern Clinical Research Unit, Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
China, Henan
Henan Cancer Hostipal
Zhengzhou, Henan, China, 450008
China, Jilin
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
China
Beijing Chao-yang Hospital
Beijing, China, 100020
Peking University People's Hospital
Beijing, China, 100044
The 307th Hospital of PLA
Beijing, China, 100071
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China, 300020
Czech Republic
Interni Hematologicka a Onkologicka Klinika
Brno, Czech Republic, 62500
Fakultni Nemocnice Hradec Kralove
Hradec Kralove, Czech Republic, 50005
Fakultni nemocnice Kralovske Vinohrady
Praha 10, Czech Republic, 10034
Finland
HUS-Kuvantaminen- Radiology Only
Helsinki, Finland, 00290
Helsingin Yliopistollinen Keskussairaala (HYKS)
Helsinki, Finland, 00290
France
CHU de Dijon-Hopital d'Enfants-Service d'hematologie Clinique
Dijon, France, 21000
C.H.U. de Grenoble, Hopital Albert Michallon
Grenoble Cedex 09, France, 38043
Hopital Universitaire Andre Mignot
Le Chesnay Cedex, France, 78157
CHU Dupuytren
Limoges Cedex, France, 87042
Institut Paoli-Calmettes
Marseille, France, 13009
Hopital Saint-louis
Paris Cedex 10, France, 75475
Centre Hospitalier Lyon Sud
Pierre Benite Cedex, France, 69495
Institut de Cancérologie Lucien Neuwirth
Saint Priest en Jarez Cedex, France, 42271
Iuct - Oncopole
Toulouse Cedex 9, France, 31059
CHU Brabois- Service d'hematologie
Vandoeuvre-les-Nancy, France, 54511
Germany
Klinikum der Goethe Universitaet, Institut
Frankfurt, Hessen, Germany, 60590
Central Apotheke
Steinbach, Hessen, Germany, 61449
Klinikum der Goethe Universitaet
Frankfurt, Germany, 60590
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Universitätsklinikum Köln, Klinik I für Innere Medizin
Köln, Germany, 50937
Klinikum Rechts der Isar der TU München
Muenchen, Germany, 81675
Universitaetsklinikum Muenster
Muenster, Germany, 48149
Institut fuer klinische Radiologie
Muenster, Germany, 48149
Hungary
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet
Budapest, Hungary, 1097
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum II. Belgyogyaszati Klinika
Debrecen, Hungary, 4032
Italy
Azienda Ospedaliera Brotzu CTMO P.O. Businco
Cagliari, CA, Italy, 09121
Farmacia (drug shipment only)
Cagliari, CA, Italy, 09121
U.O. Radiodiagnostica (Radiology only)
Cagliari, CA, Italy, 09121
Ematologia I
Genova, Genoa, Italy, 16132
Pharmacy (Drug shipment ONLY)
Genova, Genoa, Italy, 16132
Radiology Department (RAdiology ONLY)
Genova, Genoa, Italy, 16132
U.O. Ematologia 1 - IRCCS-AOU San Martino-IST
Genova, GE, Italy, 16132
Istituto di Ematologia Seragnoli
Bologna, Italy, 40138
A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto
Catania, Italy, 95124
Pharmacy (Drug Shipment Only)
Catania, Italy, 95124
Radiology (Radiology Only)
Catania, Italy, 95124
U.O. di Ematologia
Cona, Ferrara, Italy, 44124
Clinica Ematologica
Genova, Italy, 16132
IRST - Ematologia
Meldola (FC), Italy, 47014
SC Ematologia
Milano, Italy, 20162
A.O. San Gerardo di Monza
Monza, Italy, 20900
A.O. San Gerardo - Farmacia
Monza, Italy, 20900
AORN "A. Cardarelli"
Napoli, Italy, 80131
Pharmacy (Drug Shipment only)
Napoli, Italy, 80131
RAdiology Department (RAdiology only)
Napoli, Italy, 80131
Fondazione IRCSS Policlinico San Matteo
Pavia, Italy, 27100
U.O. Ematologia, Ospedale S. Maria delle Croci
Ravenna, Italy, 48121
Servizio di Farmacia (Drug Shipment Only)
Ravenna, Italy, 48121
Radiology Department (Radiology Only)
Ravenna, Italy, 48121
Clinica Ematologica
Udine, Italy, 33100
Radiology (Radiology Only)
Udine, Italy, 33100
SOC Pharmacy (Drug Shipment Only)
Udine, Italy, 33100
Japan
Nagoya Daini Red Cross Hospital
Nagoya, Aichi, Japan, 4668650
National Hospital Organization Kyushu Cancer Center
Fukuoka-shi, Fukuoka, Japan, 8111395
The Hospital of Hyogo College of Medicine
Nishinomiya-shi, Hyogo, Japan, 6638501
Tohoku University Hospital
Sendai, Miyagi, Japan, 9808574
Osaka City University Hospital
Osaka-city, Osaka, Japan, 5458586
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 1040045
Akita University Hospital
Akita, Japan, 010-8543
Tokai University Hospital
Kanagawa, Japan, 259-1193
Korea, Republic of
Chonnam National University, Hwasun Hospital
Hwasun-Gun, Jeonnam, Korea, Republic of, 519-763
Samsung Medical Center
Seoul, Korea, Republic of, 135 710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 CE
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3075 EA
Poland
Instytut Hematologii i Transfuzjologii. Klinika Hematologii
Warsaw, Mazowieckie, Poland, 02-766
Klinika Hematologii i Transplantologii
Gdansk, Poland, 80-952
Regionalny Osrodek Onkologiczny-Wojewodzki Szpital Specjalistyczny im. M. Kopernik
Lodz, Poland, 93510
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Wroclaw, Poland, 53-439
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
National University Hospital/National University Cancer Institute Singapore (NCIS)
Singapore, Singapore, 119228
Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitario de Salamanca
Salamanca, Castille and Lion, Spain, 37007
Hospital Vall D'Hebron
Barcelona, Catalonia, Spain, 08035
Hospital Son Llatzer
Palma de Mallorca, Mallorca, Spain, 07198
Hospital de la Santa Creu i Sant Pau(Nuevo Hospital)
Barcelona, Spain, 08025
Hospital Ramon y Cajal
Madrid, Spain, 28034
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital General Universitario Jose Maria Morales Meseguer
Murcia, Spain, 30008
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Sweden
Universitetssjukhus Lund, Hematologkliniken
Lund, Sweden, 221 85
Hematology Center
Stockholm, Sweden, 17176
Taiwan
Chang Gung Medical Foundation, Kaohsiung Branch
Kaohsiung, Taiwan, 83301
National Taiwan University Hospital
Taipei, Taiwan, 10002
United Kingdom
Bristol Haematology and Oncology Centre
Bristol, Avon, United Kingdom, BS2 8ED
Southampton General Hospital
Southampton, Hampshire, United Kingdom, SO16 6YD
Castle Hill Hospital
Hull, United Kingdom, HU16 5JQ
Department of Academic Oncology
London, United Kingdom, NW3 2QG
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Pfizer
UCB Pharma
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01564784     History of Changes
Other Study ID Numbers: B1931022  2011-005491-41 
Study First Received: March 26, 2012
Last Updated: July 8, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
Fludarabine phosphate
Cytarabine
Mitoxantrone
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 26, 2016