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Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL

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. Identifier: NCT00349518
Recruitment Status : Withdrawn
First Posted : July 7, 2006
Last Update Posted : February 17, 2016
Information provided by:
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.

Condition or disease Intervention/treatment Phase
Chronic Myeloid Leukemia Acute Lymphoblastic Leukemia Drug: Dasatinib Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib
Study Start Date : December 2006
Actual Primary Completion Date : January 2007

Primary Outcome Measures :
  1. Incidence and severity of drug-related adverse events.

Secondary Outcome Measures :
  1. Chronic Phase CML: Cytogenetic and Hematologic Response
  2. Advanced Phase CML and Philadelphia positive ALL: Hematologic Response
  3. Time to and duration of Cytogenetic and Hematologic Response

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Males and females, 18 or older
  • CP or AD CML or Ph+ ALL
  • Intolerant of resistant to imatinib
  • ECOG PS 0-2 (CP CML)
  • ECOG PS 0-3 (AD CML and Ph+ ALL)
  • Adequate hepatic and renal function

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • History of significant cardiac disease
  • History of significant bleeding disorder (not CML)

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 identifier (NCT number): NCT00349518

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Local Institution
Budapest, Hungary
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Bologna, Italy
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Orbassano (To), Italy
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Roma, Italy
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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Gdansk, Poland
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Warsaw, Poland
Russian Federation
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Moscow, Russian Federation
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St.Petersburg, Russian Federation
United Kingdom
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Cambridge, Cambridgeshire, United Kingdom
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Glasgow, Central, United Kingdom
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London, Greater London, United Kingdom
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Liverpool, Merseyside, United Kingdom
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Newcastle, Tyne And Wear, United Kingdom
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Birmingham, West Midlands, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Layout table for additonal information Identifier: NCT00349518    
Other Study ID Numbers: CA180-083
EUDRACTnr: 2006-001279-39
First Posted: July 7, 2006    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: April 2011
Keywords provided by Bristol-Myers Squibb:
Chronic and Advanced Phase CML and
Philadelphia Chromosome Positive ALL with imatinib intolerance or resistance
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action