Dasatinib (BMS-354825) in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

April 7, 2011 updated by: Bristol-Myers Squibb

A Phase II Study of BMS-354825 in Subjects With Lymphoid Blast Phase Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Resistant to or Intolerant of Imatinib Mesylate

The purpose of this clinical research study is to learn if BMS-354825 will have activity as defined by hematologic responses in subjects with lymphoid blast phase chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia with primary or acquired resistance to imatinib mesylate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Local Institution
      • Cordoba, Argentina
        • Local Institution
  • Australia
    • New South Wales
      • St. Leonards, New South Wales, Australia
        • Local Institution
  • Austria
      • Wien, Austria
        • Local Institution
  • Belgium
      • B-Leuven, Belgium
        • Local Institution
      • Edegem, Belgium
        • Local Institution
      • Yvoir, Belgium
        • Local Institution
  • Brazil
      • Campinas, Brazil
        • Local Institution
      • Sao Paulo, Brazil
        • Local Institution
  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada
        • Local Institution
  • Denmark
      • Aarhus, Denmark
        • Local Institution
  • Finland
      • Helsinki, Finland
        • Local Institution
  • France
      • Lille, France
        • Local Institution
      • Lyon Cedex 03, France
        • Local Institution
      • Nantes, France
        • Local Institution
      • Paris, France
        • Local Institution
      • Pessac, France
        • Local Institution
      • Poitiers Cedex, France
        • Local Institution
      • Strasbourg Cedex, France
        • Local Institution
  • Germany
      • Frankfurt/Main, Germany
        • Local Institution
      • Hamburg, Germany
        • Local Institution
      • Mainz, Germany
        • Local Institution
      • Mannheim, Germany
        • Local Institution
  • Israel
      • Ramat-Gan, Israel
        • Local Institution
  • Italy
      • Bologna, Italy
        • Local Institution
      • Orbassano, Italy
        • Local Institution
      • Roma, Italy
        • Local Institution
  • Korea, Republic of
      • Kyunggi-Do, Korea, Republic of
        • Local Institution
      • Seoul, Korea, Republic of
        • Local Institution
  • Netherlands
      • Nijmegen, Netherlands
        • Local Institution
      • Rotterdam, Netherlands
        • Local Institution
  • Norway
      • Trondheim, Norway
        • Local Institution
  • Peru
      • Lima, Peru
        • Local Institution
  • Sweden
      • Gothenburg, Sweden
        • Local Institution
      • Lund, Sweden
        • Local Institution
      • Stockholm, Sweden
        • Local Institution
      • Umea, Sweden
        • Local Institution
      • Uppsala, Sweden
        • Local Institution
  • Switzerland
      • Basel, Switzerland
        • Local Institution
  • United Kingdom
    • Central
      • Glasgow, Central, United Kingdom
        • Local Institution
    • Greater London
      • London, Greater London, United Kingdom
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Local Institution
    • California
      • Anaheim, California, United States
        • Local Institution
      • Los Angeles, California, United States
        • Local Institution
      • Stanford, California, United States
        • Local Institution
      • Vallejo, California, United States
        • Local Institution
    • Florida
      • Jacksonville, Florida, United States
        • Local Institution
      • Tampa, Florida, United States
        • Local Institution
    • Georgia
      • Atlanta, Georgia, United States
        • Local Institution
    • Illinois
      • Chicago, Illinois, United States
        • Local Institution
    • Kansas
      • Kansas City, Kansas, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
    • Missouri
      • St. Louis, Missouri, United States
        • Local Institution
    • New Jersey
      • Hackensack, New Jersey, United States
        • Local Institution
    • New York
      • New York, New York, United States
        • Local Institution
    • Oregon
      • Portland, Oregon, United States
        • Local Institution
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Local Institution
    • Tennessee
      • Nashville, Tennessee, United States
        • Local Institution
    • Texas
      • Houston, Texas, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with Philadelphia chromosome positive (Ph+) (BCR/ABL+) lymphoid blast phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
  • Subjects who are considered to have lymphoid blast phase CML if they meet at least one of the following criteria: *30% lymphoid blasts in peripheral blood or bone marrow. *Extramedullary infiltrates of leukemic cells (other than in spleen or liver) with peripheral blood lymphoid blast morphology.
  • ECOG performance status score 0-2.
  • Adequate hepatic function defined as: *Total bilirubin less than or equal to 2.0 times the institutional upper limit of normal; *alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 times the institutional upper limit of normal.
  • Adequate renal function defined as: *serum creatinine less than or equal to 1.5 times the institutional upper normal limit.
  • Men and women, 18 years of age or older.
  • 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. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IC/L or equivalent units of HCG) within 72 hours prior to the start of study medication.

Exclusion Criteria:

  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period of at least 1 month before and for at least 3 months after completion of the study medication.
  • WOCBP using a prohibited contraceptive method (not applicable).
  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period and for at least 3 months after completion of study medication.
  • Subjects who are eligible and willing to undergo transplantation during the screening period.
  • A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
  • Demential or altered mental status that would prohibit the understanding or rendering of informed consent.
  • History of significant bleeding disorder unrelated to CML.
  • Concurrent incurable malignancy other than CML.
  • Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.

  • Subjects who received any of the following:

    • imatinib mesylate within 7 days;
    • interferon or cytarabine within 14 days;
    • a targeted small molecule anti-cancer agent within 14 days;
    • any other investigational or antineoplastic agent other than hydroxyurea or anagrelide within 28 days before starting treatment with BMS-354825.
  • Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes.
  • Subjects taking medications that irreversibly inhibit platelet function.
  • Prior therapy with BMS-354825.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Dasatinib
Tablets, Oral, 70 mg, twice daily, Until disease progression or untolerable toxicity, switch to the roll-over study or study closure
Other Names:
  • BMS-354825
  • Sprycel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major and overall hematologic response rates
Time Frame: throughout the study
throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Durability of hematologic response and time to hematologic response (major and overall)
Time Frame: throughout the study
throughout the study
Assess cytogenetic and molecular responses
Time Frame: throughout the study
throughout the study
Measure minor hematologic response rate in the imatinib resistant group
Time Frame: throughout the study
throughout the study
Explore the role of BCR-ABL mRNA expression and point mutations in the BCR-ABL gene
Time Frame: throughout the study
throughout the study
Measure the heath-related QOL using FACT-G
Time Frame: throughout the study
throughout the study
To assess safety and tolerability of dasatinib
Time Frame: throughout the study
throughout the study
Population PK
Time Frame: first month
first month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

January 12, 2005

First Submitted That Met QC Criteria

January 12, 2005

First Posted (Estimate)

January 13, 2005

Study Record Updates

Last Update Posted (Estimate)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA180-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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