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BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive 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. Identifier: NCT00103701
Recruitment Status : Completed
First Posted : February 15, 2005
Last Update Posted : April 14, 2011
Information provided by:
Bristol-Myers Squibb

Brief Summary:
The purpose of this clinical research study is to understand the safety and efficacy of BMS-354825 in patients with chronic, accelerated, or blast phase chronic myelogenous leukemia (CML) or Philadelphia positive acute lymphoblastic leukemia (ALL) who are resistant to or intolerant of imatinib mesylate (Gleevec).

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Chronic-phase Leukemia, Lymphoblastic, Acute, Philadelphia-positive Drug: Dasatinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia
Study Start Date : November 2003
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Arm Intervention/treatment
Experimental: 1 Drug: Dasatinib
Tablets, Oral, 15- 240 mg, Once or twice daily, 0-3 years depending on response.
Other Name: Sprycel

Primary Outcome Measures :
  1. Establishment of MTD and recommended Phase II dose.

Secondary Outcome Measures :
  1. 1) Hematologic Response 2) Cytogenetic Response.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with Philadelphia chromosome positive, chronic, accelerated or blast phase BML or ALL.
  • Patients must have primary or acquired hematologic resistance to imatinib mesylate or have intolerance of imatinib mesylate.
  • Men and women, 14 years of age or older.
  • Adequate renal function.
  • Adequate hepatic function.
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

  • Patients who are eligible and willing to undergo transplantation during the screening period.
  • Women who are pregnant or breastfeeding.
  • A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
  • Uncontrolled or significant cardiovascular disease.
  • Medications that increase bleeding risk.
  • Medications that change heart rhythms.
  • Dementia or altered mental status that would prohibit the understanding of rendering of informed consent.
  • History of significant bleeding disorder or unrelated to CML.
  • Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

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): NCT00103701

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United States, California
Local Institution
Los Angeles, California, United States
United States, Texas
Local Institution
Houston, Texas, United States
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Layout table for additonal information Identifier: NCT00103701    
Other Study ID Numbers: CA180-002
First Posted: February 15, 2005    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011
Keywords provided by Bristol-Myers Squibb:
Chronic myelogenous leukemia (CML) chronic, accelerated, blast phase
Philadelphia chromosome positive acute (Ph+ALL)
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cell Transformation, Neoplastic
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action