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 July 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: July 11, 2014
Last verified: July 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: August 2017
Estimated Primary Completion Date: December 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
Pfizer Investigational Site Recruiting
La Jolla, California, United States, 92037
Pfizer Investigational Site Recruiting
La Jolla, California, United States, 92037-0845
Pfizer Investigational Site Recruiting
LaJolla, California, United States, 92093-0698
Pfizer Investigational Site Recruiting
Los Angeles, California, United States, 90095
Pfizer Investigational Site Recruiting
Los Angeles, California, United States, 90027
Pfizer Investigational Site Recruiting
Los Angeles, California, United States, 90033
Pfizer Investigational Site Recruiting
Orange, California, United States, 92868
Pfizer Investigational Site Recruiting
San Diego, California, United States, 92103
Pfizer Investigational Site Recruiting
Stanford, California, United States, 94305
United States, Colorado
Pfizer Investigational Site Recruiting
Aurora, Colorado, United States, 80045-0510
Pfizer Investigational Site Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Pfizer Investigational Site Recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
Pfizer Investigational Site Recruiting
Miami, Florida, United States, 33155
Pfizer Investigational Site Recruiting
Orlando, Florida, United States, 32806
United States, Georgia
Pfizer Investigational Site Recruiting
Atlanta, Georgia, United States, 30342
Pfizer Investigational Site Recruiting
Atlanta, Georgia, United States, 30322
Pfizer Investigational Site Active, not recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
Pfizer Investigational Site Recruiting
Chicago, Illinois, United States, 60611
Pfizer Investigational Site Recruiting
Chicago, Illinois, United States, 60612
Pfizer Investigational Site Recruiting
Chicago, Illinois, United States, 60637
United States, Iowa
Pfizer Investigational Site Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Pfizer Investigational Site Recruiting
Kansas City, Kansas, United States, 66160
Pfizer Investigational Site Recruiting
Westwood, Kansas, United States, 66205
United States, Kentucky
Pfizer Investigational Site Recruiting
Louisville, Kentucky, United States, 40207
Pfizer Investigational Site Recruiting
Louisville, Kentucky, United States, 40202
United States, Maryland
Pfizer Investigational Site Recruiting
Baltimore, Maryland, United States, 21287
Pfizer Investigational Site Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Pfizer Investigational Site Recruiting
Boston, Massachusetts, United States, 02215
Pfizer Investigational Site Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
Pfizer Investigational Site Recruiting
Ann Arbor, Michigan, United States, 48109
Pfizer Investigational Site Recruiting
Detroit, Michigan, United States, 48201
United States, Nebraska
Pfizer Investigational Site Recruiting
Omaha, Nebraska, United States, 68198-1210
United States, New Jersey
Pfizer Investigational Site Recruiting
Hackensack, New Jersey, United States, 07601
Pfizer Investigational Site Recruiting
New Brunswick, New Jersey, United States, 08901
United States, New Mexico
Pfizer Investigational Site Recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Pfizer Investigational Site Recruiting
Lake Success, New York, United States, 11042
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Manhasset, New York, United States, 11030
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New Hyde Park, New York, United States, 11040
Pfizer Investigational Site Recruiting
New York, New York, United States, 10065
Pfizer Investigational Site Recruiting
New York, New York, United States, 10021
Pfizer Investigational Site Recruiting
Rochester, New York, United States, 14642
Pfizer Investigational Site Recruiting
Stony Brook, New York, United States, 11794
United States, North Carolina
Pfizer Investigational Site Recruiting
Chapel Hill, North Carolina, United States, 27514
Pfizer Investigational Site Recruiting
Chapel Hill, North Carolina, United States, 27599-7600
Pfizer Investigational Site Recruiting
Charlotte, North Carolina, United States, 28204
Pfizer Investigational Site Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Pfizer Investigational Site Recruiting
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site Recruiting
Cleveland, Ohio, United States, 44106
Pfizer Investigational Site Recruiting
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Pfizer Investigational Site Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Pfizer Investigational Site Recruiting
Hershey, Pennsylvania, United States, 17033-0850
United States, South Carolina
Pfizer Investigational Site Recruiting
Charleston, South Carolina, United States, 29425
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Easley, South Carolina, United States, 29640
Pfizer Investigational Site Recruiting
Greenville, South Carolina, United States, 29605
Pfizer Investigational Site Recruiting
Greenville, South Carolina, United States, 29615
Pfizer Investigational Site Recruiting
Greer, South Carolina, United States, 29650
Pfizer Investigational Site Recruiting
Seneca, South Carolina, United States, 29672
Pfizer Investigational Site Recruiting
Spartanburg, South Carolina, United States, 29307
United States, Texas
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Dallas, Texas, United States, 75390
Pfizer Investigational Site Recruiting
Dallas, Texas, United States, 75246
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Houston, Texas, United States, 77030
Pfizer Investigational Site Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
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Salt Lake City, Utah, United States, 84143
United States, Washington
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Seattle, Washington, United States, 98109
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Seattle, Washington, United States, 98195
United States, West Virginia
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Morgantown, West Virginia, United States, 26506
Argentina
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Cordoba, Argentina, 5000
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Mendoza, Argentina, M5500AYB
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
Belgium
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Liege, Belgium, 4000
Canada, Ontario
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Toronto, Ontario, Canada, M5G 2M9
Croatia
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Zagreb, Croatia, 10000
Czech Republic
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Prague, CZ, Czech Republic, 100-34
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Brno, Czech Republic, 62500
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Brno 2, Czech Republic, 61300
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Hradec Kralove, Czech Republic, 50005
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Olomouc, Czech Republic, 77520
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Olomouc, Czech Republic, 775 20
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Praha 10, Czech Republic, 100 34
Finland
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Helsinki, Finland, 00290
France
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Angers, Cedex 01, France, 49033
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Le Chesnay, Yvelines, France, 78157
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Caen, France, 14000
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Dijon, France, 21000
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Grenoble Cedex 09, France, 38043
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Le Chesnay, France, 78150
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Limoges Cedex, France, 87042
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Marseille, France, 13009
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Mulhouse, France, 68100
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Mulhouse Cedex, France, 68070
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Paris, France, 75 679
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Paris CEDEX 10, France, 75475
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Pierre Benite Cedex, France, 69495
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Saint Priest en Jarez Cedex, France, 42271
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Toulouse Cedex 9, France, 31059
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Toulouse, Cedex 9, France, 31059
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Vandoeuvre-les-Nancy, France, 54 511
Germany
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Köln, NRW, Germany, 50937
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Frankfurt, Germany, 60590
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Freiburg, Germany, 79106
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Heidelberg, Germany, 69120
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Kiel, Germany, 24116
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Muenchen, Germany, 81675
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Muenster, Germany, 48149
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Oldenburg, Germany, 26133
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Steinbach, Germany, 61449
Hungary
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Budapest, Hungary, 1097
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Debrecen, Hungary, 4032
Italy
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Bologna, Italy, 40138
Pfizer Investigational Site Not yet recruiting
Cagliari, Italy, 09121
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Campobasso, Italy, 86100
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Catania, Italy, 95124
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Cona Ferrara, Italy, 44124
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Ferrara, Italy
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Firenze, Italy, 50134
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Genova, Italy, 16132
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Lecce, Italy, 73100
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Lecce, Italy, 73r00
Pfizer Investigational Site Recruiting
Meldola (FC), Italy, 47014
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Milano, Italy, 20162
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Modena, Italy, 41124
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Monza, Italy, 20900
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Napoli, Italy, 80131
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Pavia, Italy, 27100
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Ravenna, Italy, 48121
Pfizer Investigational Site Not yet recruiting
Rimini, Italy, 47923
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Udine, Italy, 33100
Japan
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Nagoya, Aichi, Japan
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Toon-shi, Ehime, Japan
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Osaka-city, Osaka, Japan
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Chuo-ku, Tokyo, Japan
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Komae-shi, Tokyo, Japan
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Akita, Japan
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Fukuoka, Japan
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Hyogo, Japan
Pfizer Investigational Site Recruiting
Kanagawa, Japan
Pfizer Investigational Site Recruiting
Sendai, Japan
Pfizer Investigational Site Not yet recruiting
Tokyo, Japan
Korea, Republic of
Pfizer Investigational Site Not yet recruiting
Busanjin-Gu, Busan, Korea, Republic of, 614 735
Pfizer Investigational Site Not yet recruiting
Hwasun-Gun, Jeonnam, Korea, Republic of, 519-763
Pfizer Investigational Site Not yet recruiting
Incheon, Korea, Republic of, 405-760
Pfizer Investigational Site Not yet recruiting
Seoul, Korea, Republic of, 140-743
Pfizer Investigational Site Not yet recruiting
Seoul, Korea, Republic of, 137-701
Pfizer Investigational Site Not yet recruiting
Seoul, Korea, Republic of, 110 744
Pfizer Investigational Site Recruiting
Seoul, Korea, Republic of, 135 710
Pfizer Investigational Site Recruiting
Seoul, Korea, Republic of, 138-736
Netherlands
Pfizer Investigational Site Not yet recruiting
Groningen, Netherlands, 9713 GZ
Pfizer Investigational Site Recruiting
Rotterdam, Netherlands, 3015 CE
Pfizer Investigational Site Recruiting
Rotterdam, Netherlands, 3075 EA
Poland
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Wroclaw, Silesian, Poland, 53-439
Pfizer Investigational Site Recruiting
Gdansk, Poland, 80-952
Pfizer Investigational Site Recruiting
Lodz, Poland, 93-510
Pfizer Investigational Site Recruiting
Warsaw, Poland, 02-766
Pfizer Investigational Site Recruiting
Wroclaw, Poland, 53439
Pfizer Investigational Site Recruiting
Wroclaw, Poland, 54424
Serbia
Pfizer Investigational Site Not yet recruiting
Belgrade, Serbia, 11000
Pfizer Investigational Site Not yet recruiting
Nis, Serbia, 18 000
Singapore
Pfizer Investigational Site Recruiting
Singapore, Singapore, 169608
Pfizer Investigational Site Not yet recruiting
Singapore, Singapore, 188770
Pfizer Investigational Site Recruiting
Singapore, Singapore, 119228
Slovakia
Pfizer Investigational Site Not yet recruiting
Bratislava, Slovakia, 851 07
Pfizer Investigational Site Not yet recruiting
Kosice, Slovakia, 041 66
Spain
Pfizer Investigational Site Recruiting
Badalona, Barcelona, Spain, 08916
Pfizer Investigational Site Not yet recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Pfizer Investigational Site Not yet recruiting
L'Hospitalet del Llobregat, Barcelona, Spain, 08908
Pfizer Investigational Site Not yet recruiting
Barcelona, Catalunya, Spain, 08036
Pfizer Investigational Site Recruiting
Barcelona, Catalunya, Spain, 08035
Pfizer Investigational Site Recruiting
Palma de Mallorca, Illes Balears, Spain, 07198
Pfizer Investigational Site Recruiting
Barcelona, Spain, 08025
Pfizer Investigational Site Recruiting
Madrid, Spain, 28007
Pfizer Investigational Site Not yet recruiting
Madrid, Spain, 28046
Pfizer Investigational Site Recruiting
Madrid, Spain, 28041
Pfizer Investigational Site Recruiting
Madrid, Spain, 28034
Pfizer Investigational Site Recruiting
Murcia, Spain, 30008
Pfizer Investigational Site Recruiting
Palma de Mallorca, Spain, 07198
Pfizer Investigational Site Recruiting
Salamanca, Spain, 37007
Pfizer Investigational Site Recruiting
Sevilla, Spain, 41013
Pfizer Investigational Site Recruiting
Valencia, Spain, 46010
Sweden
Pfizer Investigational Site Recruiting
Lund, Sweden, 221 85
Pfizer Investigational Site Recruiting
Stockholm, Sweden, 171 76
Pfizer Investigational Site Not yet recruiting
Uppsala, Sweden, 751 85
Taiwan
Pfizer Investigational Site Recruiting
Kaohsiung, Taiwan, 83301
Pfizer Investigational Site Not yet recruiting
Taichung, Taiwan, 40705
Pfizer Investigational Site Not yet recruiting
Taipei, Taiwan, 11217
Pfizer Investigational Site Not yet recruiting
Taipei, Taiwan, 100
United Kingdom
Pfizer Investigational Site Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Pfizer Investigational Site Recruiting
Oxford, Oxon, United Kingdom, OX3 7LJ
Pfizer Investigational Site Recruiting
Bristol, United Kingdom, BS2 8ED
Pfizer Investigational Site Recruiting
Cottingham, Hull, United Kingdom, HU16 5JQ
Pfizer Investigational Site Recruiting
Hull, United Kingdom, Hu16 5JQ
Pfizer Investigational Site Recruiting
London, United Kingdom, NW3 2QG
Pfizer Investigational Site Not yet recruiting
Manchester, United Kingdom, M20 4BX
Pfizer Investigational Site Not yet recruiting
Newcastle, United Kingdom, NE7 7DN
Pfizer Investigational Site Not yet recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Pfizer Investigational Site Recruiting
Nottingham, United Kingdom, NG5 1PB
Pfizer Investigational Site 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
Study First Received: March 26, 2012
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014