Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Pfizer
Sponsor:
Collaborator:
Union Chimique Belge
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01564784
First received: March 26, 2012
Last updated: November 25, 2014
Last verified: November 2014
  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 ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
  • 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: March 2017
Primary Completion Date: October 2014 (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
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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, California
Investigational Drug Services - UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92037-0845
UC San Diego Medical Center - La Jolla Recruiting
La Jolla, California, United States, 92037
UC San Diego Moores Cancer Center Recruiting
LaJolla, California, United States, 92093-0698
Keck Hospital of USC Recruiting
Los Angeles, California, United States, 90033
USC/Norris Comprehensive Cancer Center, Investigational Drug Service Recruiting
Los Angeles, California, United States, 90033
LAC & USC Medical Center Recruiting
Los Angeles, California, United States, 90033
UCLA Hematology/Oncology Clinic Recruiting
Los Angeles, California, United States, 90095
UCLA Ronald Reagan Medical Center Recruiting
Los Angeles, California, United States, 90095
Children's Center for Cancer and Blood Diseases, Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
USC/Norris Comprehensive Cancer Center /Investigational Drug Services Recruiting
Los Angeles, California, United States, 90033
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Stanford University Cancer Clinical Trials Office Recruiting
Palo Alto, California, United States, 94304
Stanford University Hospital and Clinics - Clinical Translation Research Unit Recruiting
Palo Alto, California, United States, 94304
UC San Diego Medical Center - Hillcrest Recruiting
San Diego, California, United States, 92103
Stanford Cancer Institute Recruiting
Stanford, California, United States, 94305
Stanford University Hospital and Clinics Recruiting
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
University of Colorado Hospital, Cancer Center Infusion Center Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Smilow Cancer Center at Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Smilow Cancer Center at Yale New Haven Hospital (Drug Shipment Address) Recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
UF Health Shands Hospital Not yet recruiting
Gainesville, Florida, United States, 32610
UF Health Shands Cancer Hospital Not yet recruiting
Gainesville, Florida, United States, 32608
Miami Children's Hospital Recruiting
Miami, Florida, United States, 33155
Orlando Regional Medical Center Recruiting
Orlando, Florida, United States, 32806
M.D. Anderson Cancer Center Orlando Recruiting
Orlando, Florida, United States, 32806
Orlando Heart Health Institute Recruiting
Orlando, Florida, United States, 32806
MD Anderson Cancer Center Orlando - 5th Floor Investigational Pharmacy Recruiting
Orlando, Florida, United States, 32806
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33612
H. Lee Moffitt Cancer Center & Research Institute Recruiting
Tampa, Florida, United States, 33626
United States, Georgia
Winship Cancer Institute, Emory University Recruiting
Atlanta, Georgia, United States, 30322
Emory University Clinic - Investigational Drug Service Recruiting
Atlanta, Georgia, United States, 30322
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
The Emory Clinic Recruiting
Atlanta, Georgia, United States, 30322
Blood and Marrow Transplant Group of Georgia Recruiting
Atlanta, Georgia, United States, 30342
Georgia Regents Medical Center Pharmacy, Georgia Regents University Cancer Center Active, not recruiting
Augusta, Georgia, United States, 30912
Georgia Regents University Active, not recruiting
Augusta, Georgia, United States, 30912
MCG Health Pharmacy Active, not recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
Rush University Medical Center, Division of Hematology/Pathology Recruiting
Chicago, Illinois, United States, 60612
Northwestern Memorial Hospital - Drug Shipment Address Recruiting
Chicago, Illinois, United States, 60611
Northwestern University, Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Northwestern Medical Faculty Foundation (NMFF) Recruiting
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Hospital Recruiting
Kansas City, Kansas, United States, 66160
University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40202
Norton Cancer Institute, Suburban Recruiting
Louisville, Kentucky, United States, 40207
United States, Maryland
University of Maryland Baltimore Recruiting
Baltimore, Maryland, United States, 21201
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02284-9168
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
University of Massachusetts Worcester Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Health System- Recruiting
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Barbara Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
United States, Nebraska
The Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-1210
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
John Theurer Cancer Center at Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
The Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08901
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
UNM Cancer Center IP Only Recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
Monter Cancer Center Recruiting
Lake Success, New York, United States, 11042
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
New York Presbyterian Hospital - Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
New York Presbyterian Hospital - Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
University of Rochester Recruiting
Rochester, New York, United States, 14642
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794-9447
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794-7007
United States, North Carolina
UNC Hospitals - The University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7600
UNC Cancer Hospital Infusion Pharmacy Recruiting
Chapel Hill, North Carolina, United States, 27514
Carolinas Medical Centre-Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Investigational Pharmacy Recruiting
Charlotte, North Carolina, United States, 28204
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
University Hospitals Case Medical Center - Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
United States, Oklahoma
OU Medical Center Presbyterian Tower Recruiting
Oklahoma City, Oklahoma, United States, 73104
Peggy and Charles Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center, Recruiting
Hershey, Pennsylvania, United States, 17033-0850
United States, South Carolina
Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
MUSC Hospital Recruiting
Charleston, South Carolina, United States, 29425
MUSC Investigational Drug Services Recruiting
Charleston, South Carolina, United States, 29425
United States, Texas
Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Parkland Memorial Hospital Recruiting
Dallas, Texas, United States, 75235
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8565
UT Southwestern University Hospital- Zale Lipshy Recruiting
Dallas, Texas, United States, 75390
UT Southwestern Medical Center: Simmons Pharmacy Recruiting
Dallas, Texas, United States, 75390-9015
UT Southweastern University Hospital- St. Paul Recruiting
Dallas, Texas, United States, 75235
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Methodist Healthcare System of San Antonio dba Methodist Hospital Recruiting
San Antonio, Texas, United States, 78229
Methodist Hospital Investigational Pharmacy Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
United States, West Virginia
West Virginia University Hospitals Recruiting
Morgantown, West Virginia, United States, 26506
West Virginia University Hospitals Pharmaceutical Services Recruiting
Morgantown, West Virginia, United States, 26506
Argentina
Sanatorio Allende Recruiting
Cordoba, Argentina, 5000
Fundacion Centro Oncologico de Integracion Regional (C.O.I.R.) Not yet recruiting
Mendoza, Argentina, M5500AYB
Australia, South Australia
Royal Adelaide Hospital (RAH) - Chest Clinic Not yet recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Eastern Clinical Research Unit Recruiting
Box Hill, Victoria, Australia, 3128
Belgium
University Hospital Gent Not yet recruiting
Gent, Belgium, 9000
Centre Hospitalier Universitaire de Liege-Sart Tilman Not yet recruiting
Liege, Belgium, 4000
Brazil
Clinicas Oncologicas Integradas (COI) - Instituto COI de Pesquisa, educacao e Gestao Not yet recruiting
Barra da Tijuca, Rio de Janeiro, Brazil, 22793-080
CDPI (Clinica de Diagnostico por Imagem) MRI Only Not yet recruiting
Rio de Janeiro, RJ, Brazil, 22440-031
Labs Cardiolab Exames Complementares S/A Not yet recruiting
Rio de Janeiro, RJ, Brazil, 20941-150
AFIP (Bone marrow Biopsy) Not yet recruiting
Sao Paulo, SP, Brazil, 04020-060
HOSPITAL BANDEIRANTES (Rx, ECG, EC, CT, NMR) Not yet recruiting
Sao Paulo, SP, Brazil, 01507-000
IEP Sao Lucas Not yet recruiting
Sao Paulo, SP, Brazil, 01236-030
Hospital Bandeirantes (Lab tests) Not yet recruiting
São Paulo, SP, Brazil, 01507-000
Neurolife Laboratorios Not yet recruiting
Rio de Janeiro, Brazil, 22210-4731
Hemorio - Instituto Estadual de Hematologia Arthur Siqueira Not yet recruiting
Rio de Janeiro, Brazil, 20211-030
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
China, Fujian
Fujian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China, 350001
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Nanfang Hospital, Southern Medical University Not yet recruiting
Guangzhou, Guangdong, China, 510515
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450008
China, Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430022
China, Jiangsu
Jiangsu Province Hospital Not yet recruiting
Nanjing, Jiangsu, China, 210029
China, Jilin
The first hospital of jilin university Recruiting
Changchun, Jilin, China, 130021
China, Shanxi
Shanxi Medical University Second Hospital Recruiting
Taiyuan, Shanxi, China, 30001
Tangdu Hospital of the Fourth Military Medical University Recruiting
Xi'an, Shanxi, China, 710038
China, Zhejiang
The First Affiliated Hospital of College of Medicine, Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China, 310003
China
Beijing Chao-yang Hospital Recruiting
Beijing, China, 100020
Peking University People's Hospital Not yet recruiting
Beijing, China, 100044
Peking University Third Hospital Not yet recruiting
Beijing, China, 100191
The 307th Hospital of PLA Recruiting
Beijing, China, 100071
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences Recruiting
Tianjin, China, 300020
Croatia
Clinical Hospital Merkur, Department of Internal Medicine, Division of Hematology Not yet recruiting
Zagreb, Croatia, 10000
University Hospital Center Zagreb Not yet recruiting
Zagreb, Croatia, 10000
Czech Republic
Fakultni nemocnice Kralovske Vinohrady Not yet recruiting
Prague, CZ, Czech Republic, 100-34
Fakultni Nemocnice Brno Recruiting
Brno, Czech Republic, 62500
Interni Hematologicka a Onkologicka Klinika Recruiting
Brno, Czech Republic, 62500
Fakultni Nemocnice Brno - Detska nemocnice - Klinika Detskych Infekcnich Nemoci Recruiting
Brno 2, Czech Republic, 61300
Fakultni Nemocnice Hradec Kralove Recruiting
Hradec Kralove, Czech Republic, 50005
Fakultni nemocnice Olomouc Not yet recruiting
Olomouc, Czech Republic, 77520
Oddeleni pripavy cytostatik Not yet recruiting
Olomouc, Czech Republic, 775 20
Ustavni Lekarna Fakultni nemocnice Not yet recruiting
Praha 10, Czech Republic, 100 34
Finland
Helsinki university hospital Recruiting
Helsinki, Finland, 00290
France
CHU d'Angers Not yet recruiting
Angers, Cedex 01, France, 49033
Hopital Universitaire Andre Mignot Recruiting
Le Chesnay Cedex, Yvelines, France, 78157
CHU de Caen Not yet recruiting
Caen, France, 14000
CHU de Dijon-Hopital d'Enfants-Service d'hematologie Clinique Recruiting
Dijon, France, 21000
C.H.U. de Grenoble, Hopital Albert Michallon Recruiting
Grenoble Cedex 09, France, 38043
CHU Dupuytren Recruiting
Limoges Cedex, France, 87042
Institut Paoli-Calmettes Recruiting
Marseille, France, 13009
Centre hospitalier de Mulhouse - Hôpital Emile Muller Not yet recruiting
Mulhouse, France, 68100
Centre Hospitalier de Mulhouse - Hopital Emile Muller Not yet recruiting
Mulhouse Cedex, France, 68070
Hopital Cochin - Service D'hematologie Not yet recruiting
Paris, France, 75 679
Hopital Saint-louis Recruiting
Paris CEDEX 10, France, 75475
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite Cedex, France, 69495
Institut de Cancérologie Lucien Neuwirth Recruiting
Saint Priest en Jarez Cedex, France, 42271
PHARMACIE - Unité des Essais Cliniques Recruiting
Toulouse Cedex 9, France, 31059
Hopital Purpan Recruiting
Toulouse, Cedex 9, France, 31059
Hopital d'adultes de Brabois, Centre Hospitalier Regional Universitaire CHU NANCY Brabois Recruiting
Vandoeuvre-les-Nancy, France, 54 511
Germany
Klinikum der Goethe Universitaet, Institut Recruiting
Frankfurt, Hessen, Germany, 60590
Central Apotheke Recruiting
Steinbach, Hessen, Germany, 61449
Universitatsklinikum Köln Recruiting
Köln, NRW, Germany, 50937
Klinikum der Goethe Universitaet Recruiting
Frankfurt, Germany, 60590
Universitätsklinikum Freiburg, Medizinische Klinik Not yet recruiting
Freiburg, Germany, 79106
Universitaetsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69120
Staedtisches Krankenhaus Kiel GmbH, Not yet recruiting
Kiel, Germany, 24116
Klinikum Rechts der Isar der TU München Recruiting
Muenchen, Germany, 81675
Institut fuer klinische Radiologie Recruiting
Muenster, Germany, 48149
Universitaetsklinikum Muenster Recruiting
Muenster, Germany, 48149
Klinikum Oldenburg Not yet recruiting
Oldenburg, Germany, 26133
Hungary
Egyesitett Szent Istvan es Szent Laszlo Kh.-Rendeloint./Haematologia es Ossejt-transzplant. Oszt. Recruiting
Budapest, Hungary, 1097
Euromedic Diagnostic KFT Recruiting
Budapest, Hungary, 1076
Euromedic Diagnostics Magyarorszag Kft- Radiology Only Recruiting
Budapest, Hungary, 1076
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum II. Belgyogyaszati Klinika Recruiting
Debrecen, Hungary, 4032
Italy
U.O. Ematologia Recruiting
Ravenna, RA, Italy, 48121
Istituto di Ematologia e Scienze Oncologiche "L. e A. Seragnoli", Policlinico Sant'Orsola Malpighi Recruiting
Bologna, Italy, 40138
Pharmacy Operative Unit (Drug Shipment Only) Recruiting
Bologna, Italy, 40138
Radiology Department (Radiology Only) Recruiting
Bologna, Italy, 40138
Struttura Complessa di Ematologia e CTMO, Centro di Riferimento Oncologico Regionale Recruiting
Cagliari, Italy, 09121
Radiology Department (Radiology Only) Recruiting
Campobasso, Italy, 86100
Fondazione di Ricerca e Cura Giovanni Paolo II Recruiting
Campobasso, Italy, 86100
Pharmacy (Drug Shipment Only) Recruiting
Campobasso, Italy, 86100
A.O.U. Vittorio Emanuele di Catania - Ospedale Ferrarotto Recruiting
Catania, Italy, 95124
U.O. di Ematologia Recruiting
Cona Ferrara, Italy, 44124
Farmacia Arcispedale S. Anna Recruiting
Ferrara, Italy
SOD Radiodiagnostica (Radiology Only) Not yet recruiting
Firenze, Italy, 50134
SOD Ematologia- DAI Oncologia Not yet recruiting
Firenze, Italy, 50134
SOD Pharmacy (Drug Shipment Only) Not yet recruiting
Firenze, Italy, 50134
AOU Careggi- SOD Ematologia- DAI Oncologia Not yet recruiting
Firenze, Italy, 50134
Azienda Ospedaliera Universitaria "San Martino" (Ospedale San Martino),Universita Degli Studi Recruiting
Genova, Italy, 16132
IRCCS AOU S. Martino - IST Recruiting
Genova, Italy, 16132
U.O. Ematologia 1 Recruiting
Genova, Italy, 16132
U.O.C. Ematologia Not yet recruiting
Lecce, Italy, 73r00
P.O. Vito Fazzi - UOC Ematologia Not yet recruiting
Lecce, Italy, 73100
Farmacia U.M.A.C.A. Not yet recruiting
Lecce, Italy, 73100
IRST - Ematologia Recruiting
Meldola (FC), Italy, 47014
Niguarda Ca' Granda Hospital Milano Recruiting
Milano, Italy, 20162
S.C. Pharmacy Recruiting
Milano, Italy, 20162
S.C. Radiology Recruiting
Milano, Italy, 20162
S.C. Ematologia, D.A.I. Oncologia, Ematologia e Patologie dell'apparato Respiratorio Not yet recruiting
Modena, Italy, 41124
Radiology ONLY Recruiting
Monza, Italy, 20900
Pharmacy ONLY/Dispensing ONLY Recruiting
Monza, Italy, 20900
A.O. San Gerardo - Farmacia Recruiting
Monza, Italy, 20900
AORN "A. Cardarelli" Recruiting
Napoli, Italy, 80131
Clinica Ematologica Recruiting
Pavia, Italy, 27100
Radiology Department (Radiology Only) Recruiting
Pavia, Italy, 27100
S.C. Farmacia c/o C.U.R.M, (Drug Shipment Only) Recruiting
Pavia, Italy, 27100
Radiology Department (Radiology Only) Recruiting
Ravenna, Italy, 48121
Servizio di Farmacia (Drug Shipment Only) Recruiting
Ravenna, Italy, 48121
U.O. Ematologia, Ospedale S. Maria delle Croci Recruiting
Ravenna, Italy, 48121
U.O. Ematologia Ospedale Infermi Not yet recruiting
Rimini, Italy, 47923
Azienda Ospedaliero Universitaria di Udine, Santa Maria della Misericordia Recruiting
Udine, Italy, 33100
Local Laboratory Recruiting
Udine, Italy, 33100
SOC Pharmacy (Drug Shipment Only) Recruiting
Udine, Italy, 33100
Radiology (Radiology Only) Recruiting
Udine, Italy, 33100
Pathological Anatomy Laboratory Recruiting
Udine, Italy, 33100
Japan
Nagoya Daini Red Cross Hospital Recruiting
Nagoya, Aichi, Japan, 4668650
Ehime University Hospital Not yet recruiting
Toon-shi, Ehime, Japan, 791-0295
Tohoku University Hospital Recruiting
Sendai, Miyagi, Japan, 9808574
Osaka City University Hospital Recruiting
Osaka-city, Osaka, Japan, 545-8586
National Cancer Center Hospital Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Jikei University Hospital Daisan Not yet recruiting
Komae-shi, Tokyo, Japan, 2018601
Akita University Hospital Recruiting
Akita, Japan, 010-8543
National Kyushu Cancer Center Recruiting
Fukuoka, Japan, 811-1395
The Hospital of Hyogo College of Medicine Recruiting
Hyogo, Japan, 663-8501
Tokai University Hospital Recruiting
Kanagawa, Japan, 259-1193
Cancer Institute Hospital, Japanese Foundation for Cancer Research Not yet recruiting
Tokyo, Japan, 135-8550
Korea, Republic of
Inje University Busan Paik Hospital Not yet recruiting
Busanjin-Gu, Busan, Korea, Republic of, 614 735
Chonnam National University, Hwasun Hospital Recruiting
Hwasun-Gun, Jeonnam, Korea, Republic of, 519-763
Gachon University Gil Medical Center Not yet recruiting
Incheon, Korea, Republic of, 405-760
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 110 744
Catholic University of Korea, Seoul St.Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of, 137-701
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135 710
Asan Medical Center, Department of Hematology Recruiting
Seoul, Korea, Republic of, 138-736
Soonchunhyang University Hospital Not yet recruiting
Seoul, Korea, Republic of, 140-743
Netherlands
Erasmus Medical Center Recruiting
Rotterdam, South Holland, Netherlands, 305 CE
Erasmus Medical Center Recruiting
Rotterdam, South Holland, Netherlands, 3075 EA
University Medical Center Groningen Not yet recruiting
Groningen, Netherlands, 9713 GZ
Poland
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii Recruiting
Gdansk, Poland, 80-952
Medical University of Lodz Recruiting
Lodz, Poland, 93-510
Instytut Hematologii i Transfuzjologii. Klinika Hematologii Recruiting
Warsaw, Poland, 02-766
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku Recruiting
Wroclaw, Poland, 53-439
Serbia
Military Medical Academy Not yet recruiting
Belgrade, Serbia, 11000
Laboratory of Institute for Oncology and Radiology of Serbia Not yet recruiting
Belgrade, Serbia, 11000
Clinic for Hematology, Clinical Center of Serbia Not yet recruiting
Belgrade, Serbia, 11000
Clinical Centre Nis, Clinic of Haematology Not yet recruiting
Nis, Serbia, 18 000
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
National University Hospital/National University Cancer Institute Singapore (NCIS) Recruiting
Singapore, Singapore, 119228
Raffles Hospital Not yet recruiting
Singapore, Singapore, 188770
Slovakia
Univerzitna nemocnica Bratislava, Klinika hematologie a transfuziologie Not yet recruiting
Bratislava, Slovakia, 851 07
Univerzitna nemocnica L. Pasteura Kosice Not yet recruiting
Kosice, Slovakia, 041 66
Spain
ICO-Hospital Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
ICO Hospitalet. Hospital Duran i Reynals Not yet recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
ICO Hospitalet. Hospital Duran i Reynals - Servicio de Farmacia Not yet recruiting
L'Hospitalet del Llobregat, Barcelona, Spain, 08908
Hospital Clinic i Provincial de Barcelona Not yet recruiting
Barcelona, Catalunya, Spain, 08036
Hospital Vall d'Hebron Recruiting
Barcelona, Catalunya, Spain, 08035
Hospital Son Llatzer Recruiting
Palma de Mallorca, Illes Balears, Spain, 07198
Hospital de la Santa Creu i Sant Pau(Nuevo Hospital) Recruiting
Barcelona, Spain, 08025
Pharmacy - Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Hospital 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital General Universitario Gregorio Maranon Recruiting
Madrid, Spain, 28007
Hospital La Paz - Farmacia Not yet recruiting
Madrid, Spain, 28046
Hospital Ramon y Cajal Recruiting
Madrid, Spain, 28034
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain, 28046
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital General Universitario Jose Maria Morales Meseguer Recruiting
Murcia, Spain, 30008
Pharmacy - Hospital General Universitario Jose Maria Morales Meseguer Recruiting
Murcia, Spain, 30008
Pharmacy - Hospital Son LLatzer Recruiting
Palma de Mallorca, Spain, 07198
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Complejo Hospitalario Nuestra Senora De Valme Not yet recruiting
Sevilla, Spain, 41014
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Sweden
Universitetssjukhus Lund, Hematologkliniken Recruiting
Lund, Sweden, 221 85
Karolinska Universitetssjukhuset Solna Recruiting
Stockholm, Sweden, 171 76
Akademiska Sjukhuset Uppsala Not yet recruiting
Uppsala, Sweden, 751 85
Taiwan
Chang Gung Medical Foundation, Kaohsiung Branch Recruiting
Kaohsiung, Taiwan, 83301
Taichung Veterans General Hospital Not yet recruiting
Taichung, Taiwan, 40705
National Taiwan University Hospital, Department of Internal Medicine Not yet recruiting
Taipei, Taiwan, 100
Taipei Veterans General Hospital Not yet recruiting
Taipei, Taiwan, 11217
United Kingdom
Southampton General Hospital Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Churchill Hospital Recruiting
Oxford, Oxon, United Kingdom, OX3 7LJ
Local Laboratory (used for safety samples) Recruiting
Hull, Yorkshire, United Kingdom, HU16 5JQ
Biochemistry & Haematology Department. Recruiting
Hull, Yorkshire, United Kingdom, HU16 5JQ
St James Hospital (used for cytogenetic testing) Recruiting
Leeds, Yorkshire, United Kingdom, LS9 7LS
Bristol Haematology and Oncology Centre Recruiting
Bristol, United Kingdom, BS2 8ED
Academic Oncology Recruiting
Cottingham, United Kingdom, HU16 5JQ
Castle Hill Hospital Recruiting
Hull, United Kingdom, HU16 5JQ
Department of Academic Oncology Recruiting
London, United Kingdom, NW3 2QG
The Christie NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M20 4BX
Clinical Trials Pharmacy Not yet recruiting
Newcastle, United Kingdom, NE7 7DN
Specialist Haematology Department, Level 4, NCCC Not yet recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
Central South Coast Cancer Research Network Recruiting
Southampton, United Kingdom, SO16 6YD
University Hospital Southampton NHS Foundation Trust Recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Pfizer
Union Chimique Belge
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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: November 25, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014