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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01564784
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : August 2, 2012
Actual Primary Completion Date : March 8, 2016
Actual Study Completion Date : January 4, 2017


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC) [ Time Frame: Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose ]
    CR was the disappearance of leukemia indicated by less than (<) 5 percent (%) marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) & platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable & non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm & ≤1.5 cm in GTD at baseline must have regressed to <1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen & other previously enlarged organs must have regressed in size & must not be palpable) was required. CRi was defined as CR except ANC <1000/μL &/or platelets <100,000/μL.

  2. Overall Survival (OS) [ Time Frame: Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first. ]
    OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact.


Secondary Outcome Measures :
  1. Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment) [ Time Frame: Up to 2 years from randomization ]
    DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e. death, progressive disease [objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status] or starting new induction therapy or post-therapy stem cell transplant [SCT] without achieving CR/CRi). Responders without PFS events were censored at the last valid disease assessment including follow-up.

  2. Progression-Free Survival (PFS) [ Time Frame: Up to 2 years from randomization ]
    PFS was defined as time from date of randomization to earliest date of the following events: death, progressive disease (objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status) and starting new induction therapy or post-therapy SCT without achieving CR/CRi. Participants without a PFS event at time of analysis were censored at the last valid disease assessment. In addition, participants with documentation of an event after an unacceptably long interval (>28 weeks if there was post-baseline disease assessment, or >12 weeks if there was no post-baseline assessment) since the previous disease assessment were censored at the time of the previous assessment (date of randomization if no post-baseline assessment). Post-study treatment follow-up disease assessments was included. Kaplan-Meier method used and 2-sided 95% confidence interval (CI) calculated based on the Brookmeyer and Crowley method.

  3. Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT) [ Time Frame: Up to 19 weeks from last dose ]
    HSCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin or Investigator's choice of chemotherapy.

  4. Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment) [ Time Frame: Up to approximately 4 weeks (EoT) from last dose of study drug ]
    MRD analysis was performed at least once in participants with prior assessment of CR or CRi. Bone marrow aspirates, collected at screening and during the study, were sent to the central laboratory and analyzed using multiparametric flow cytometry. The antibody combinations were designed to maximize discrimination between normal and abnormal cells of B-cell lineage and similar maturational stage and included antibodies detecting cluster of differentiation (CD) 9, CD10, CD13, CD19, CD20, CD33, CD34, CD38, CD45, CD58, CD66c, and CD123. A peripheral blood sample was provided if a participant had an inadequate bone marrow aspirate at screening. MRD negativity was considered to have been achieved if the lowest value of MRD from the first date of CR/CRi to EoT was <1 × 10^-4 blasts/nucleated cells.

  5. Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment) [ Time Frame: Up to approximately 4 weeks (EoT) from last dose of study drug ]
    Karyotyping was required locally, at screening and at least once during the study in participants who had abnormal cytogenetics at baseline and who achieved CR/CRi. Data presented below are for participants who achieved CR/CRi per EAC and had abnormal karyotype at screening.

  6. Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing [ Time Frame: Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4 ]
    Blood samples were collected and analyzed for inotuzumab ozogamicin serum concentrations using a validated high performance liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) method with a lower limit of quantification of 1.0 nanograms per milliliter (ng/mL). Cmax was the maximum observed concentration occurring between 0-8 hours post-dose. Ctrough was the concentration prior to subsequent dose (pre-dose) occurring after 8 hours. n = number of observations (non-missing concentrations).

  7. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score [ Time Frame: Day 1 of each cycle prior to dosing and EoT ]
    This questionnaire comprised 30 questions within which are 9 multi-item scales & 6 single-item measures. There are 5 functional scales; physical, role, cognitive, emotional & social, 3 symptom scales; fatigue, pain, & nausea & vomiting, & a global health status/quality of life (QoL) scale. There are 5 single item measures assessing additional symptoms commonly reported by cancer patients (loss of appetite, insomnia, constipation, diarrhea, & dyspnea) & a single item concerning perceived financial impact of the disease. Most questions used a 4 point scale (1='not at all' to 4='very much'); 2 questions used a 7-point scale (1='very poor' to 7='excellent'). Scores were averaged & transformed to a scale ranging from 0 to 100; a higher score indicates a better level of functioning or greater degree of symptoms.

  8. Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score [ Time Frame: Day 1 of each cycle prior to dosing and EoT ]
    The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).

  9. Change From Baseline in EQ-5D VAS [ Time Frame: Day 1 of each cycle prior to dosing and EoT ]
    The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.

  10. Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT [ Time Frame: Up to 2 years from randomization ]
    VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564784


  Hide Study Locations
Locations
United States, California
Investigational Drug Services - UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037-0845
UC San Diego Medical Center - La Jolla
La Jolla, California, United States, 92037
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093-0698
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
LAC+USC Medical Center
Los Angeles, California, United States, 90033
USC Norris Comprehensive Cancer Center
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 Drug Information/Investigation Drug
Los Angeles, California, United States, 90095
UCLA Hematology/Oncology Clinic
Los Angeles, California, United States, 90095
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
UCLA Rrmc
Los Angeles, California, United States, 90095
UC Irvine Medical Center
Orange, California, United States, 92868-3201
Children's Hospital of Orange County
Orange, California, United States, 92868
UC Irvine Medical Center
Orange, California, United States, 92868
Freidenrich Center for Translational Research (CTRU), Stanford University
Palo Alto, California, United States, 94304
UC San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103
Martha Hamilton, Investigational Drug Services, Dept of Pharmacy
Stanford, California, United States, 94305
Stanford Cancer Institute
Stanford, California, United States, 94305
Stanford University Hospital and Clinics
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
University of Colorado Hospital, Cancer Center Infusion Center
Aurora, Colorado, United States, 80045
University of Colorado Hospital
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 Hospital
Atlanta, Georgia, United States, 30322
Investigational Drug Service, Emory University Clinic
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
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
Northwestern Medicine Developmental Therapeutics Institute
Chicago, Illinois, United States, 60611
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
The University of Chicago
Chicago, Illinois, United States, 60637
University of Chicago Medical Center, Dept. of Pharmacy
Chicago, Illinois, United States, 60637
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
Louisville, Kentucky, United States, 40202
Norton Cancer Institute, Suburban
Louisville, Kentucky, United States, 40207
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Oncology Investigational Drug Service
Baltimore, Maryland, United States, 21231-2410
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231-2410
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
Farmington 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 Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87131-0001
UNM Cancer Center
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, 10021
NewYork-Presbyterian Hospital
New York, New York, United States, 10065
Weill Cornell Medical College - New York-Presbyterian Hospital
New York, New York, United States, 10065
University of Rochester Medical Center
Rochester, New York, United States, 14642
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
Division of Hematology/Oncology, Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Stony Brook University Medical Center
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
IDS-investigational drug pharmacy Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Penn State Milton S. Hershey Medical Center,
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Drug Shipment/Storage Address (MUSC Investigational Drug Services)
Charleston, South Carolina, United States, 29425
Hollings Cancer Center
Charleston, South Carolina, United States, 29425
MUSC Hospital
Charleston, South Carolina, United States, 29425
United States, Texas
Parkland Health and Hospital System
Dallas, Texas, United States, 75235
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Baylor University Medical Center
Dallas, Texas, United States, 75246
Drug Shipment Address: UT Southwestern medical Center: Simmons Pharmacy
Dallas, Texas, United States, 75390-9015
University of Texas Southwestern Universtiy Hospital - William P Clements Jr.
Dallas, Texas, United States, 75390
UT Southwestern Medical Center at Dallas
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 Cancer Centre
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
Czechia
Interni Hematologicka a Onkologicka Klinika
Brno, Czechia, 62500
Fakultni Nemocnice Hradec Kralove
Hradec Kralove, Czechia, 50005
Fakultni nemocnice Kralovske Vinohrady
Praha 10, Czechia, 10034
Finland
HUS-Kuvantaminen
Helsinki, Finland, 00290
HYKS/Hematologian klinikka
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
Hôpital 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
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
Hungary
Egyesitett Szent Istvan és 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
Cagliari, CA, Italy, 09121
U.O. Radiodiagnostica
Cagliari, CA, Italy, 09121
IRST-Ematologia
Meldola (FC), FC, Italy, 47014
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 Dip. Medicine Specialistiche A.O.U. Arcispedale Sant'Anna
Cona, Ferrara, Italy, 44124
Clinica Ematologica
Genova, Italy, 16132
Pharmacy (Drug Shipment ONLY)
Genova, Italy, 16132
Pharmacy
Genova, Italy, 16132
Radiology Department (Radiology ONLY)
Genova, Italy, 16132
Radiology Department
Genova, Italy, 16132
U.O. Ematologia 1
Genova, Italy, 16132
S.C. Pharmacy
Milano, Italy, 20162
S.C. Radiology
Milano, Italy, 20162
SC Ematologia
Milano, Italy, 20162
A.O. San Gerardo - Farmacia
Monza, Italy, 20900
A.O. San Gerardo di Monza
Monza, Italy, 20900
AORN "A. Cardarelli"
Napoli, Italy, 80131
Pharmacy (Drug Shipment only)
Napoli, Italy, 80131
RAdiology Department (RAdiology only)
Napoli, Italy, 80131
Clinica Ematologica
Pavia, Italy, 27100
Radiologist Department
Ravenna, Italy, 48121
Servizio di Farmacia
Ravenna, Italy, 48121
U.O. Ematologia, Ospedale S. Maria delle Croci
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
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
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 8111395
Tokai University Hospital
Kanagawa, Japan, 259-1193
Korea, Republic of
Chonnam National University, Hwasun Hospital
Hwasun-Gun, Jeonnam, Korea, Republic of, 519-763
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 135 710
Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 CE
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3075 EA
Poland
Klinika Hematologii i Transplantologii
Gdansk, Poland, 80-952
Oddzial Hematologii, Klinika Hematologii, Regionalny Osrodek Onkologiczny Wojewodzki Szpital
Lodz, Poland, 93510
Instytut Hematologii i Transfuzjologii, Klinika Hematologii
Warsaw, Poland, 02-776
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Wroclaw, Poland, 53-439
Singapore
National University Hospital/National University Cancer Institute Singapore (NCIS)
Singapore, Singapore, 119228
Singapore General Hospital
Singapore, Singapore, 169608
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 General Universitario Gregorio Maranon
Madrid, Spain, 28007
Hospital Ramon y Cajal
Madrid, Spain, 28034
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
Southampton General Hospital
Southampton, Hampshire, United Kingdom, SO16 6YD
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01564784     History of Changes
Other Study ID Numbers: B1931022
2011-005491-41 ( EudraCT Number )
First Posted: March 28, 2012    Key Record Dates
Results First Posted: January 17, 2018
Last Update Posted: January 17, 2018
Last Verified: December 2017

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