A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate

February 4, 2010 updated by: Bristol-Myers Squibb

Study of Dasatinib (BMS-354825) in Subjects With Chronic Myelogenous Leukemia With Accelerated or Myeloid or Lymphoid Blast Phase or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant to or Intolerant of Imatinib Mesylate

The purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The safety of the treatment will also be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Local Institution
    • Ontario
      • Hamilton, Ontario, Canada
        • Local Institution
      • Toronto, Ontario, Canada
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada
        • Local Institution
  • United States
    • California
      • Corona, California, United States
        • Local Institution
    • Colorado
      • Aurora, Colorado, United States
        • Local Institution
      • Colorado Springs, Colorado, United States
        • Local Institution
    • Connecticut
      • Waterford, Connecticut, United States
        • Local Institution
    • Florida
      • Daytona Beach, Florida, United States
        • Local Institution
      • Jupiter, Florida, United States
        • Local Institution
    • Georgia
      • Atlanta, Georgia, United States
        • Local Institution
      • Lawrenceville, Georgia, United States
        • Local Institution
    • Indiana
      • Beach Grove, Indiana, United States
        • Local Institution
      • Indianapolis, Indiana, United States
        • Local Institution
    • Iowa
      • Iowa City, Iowa, United States
        • Local Institution
    • Kansas
      • Kansas City, Kansas, United States
        • Local Institution
      • Salina, Kansas, United States
        • Local Institution
    • Kentucky
      • Lexington, Kentucky, United States
        • Local Institution
      • Louisville, Kentucky, United States
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States
        • Local Institution
    • Michigan
      • Ann Arbor, Michigan, United States
        • Local Institution
      • Detroit, Michigan, United States
        • Local Institution
    • New Mexico
      • Santa Fe, New Mexico, United States
        • Local Institution
    • New York
      • New York, New York, United States
        • Local Institution
    • Ohio
      • Cincinnati, Ohio, United States
        • Local Institution
      • Cleveland, Ohio, United States
        • Local Institution
    • Oklahoma
      • Lawton, Oklahoma, United States
        • Local Institution
      • Tulsa, Oklahoma, United States
        • Local Institution
    • Oregon
      • Portland, Oregon, United States
        • Local Institution
    • Rhode Island
      • Providence, Rhode Island, United States
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, United States
        • Local Institution
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Local Institution
    • Washington
      • Spokane, Washington, United States
        • Local Institution
    • Wisconsin
      • Sheboygan, Wisconsin, 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:

  • Diagnosis of accelerated phase or blast phase CML or Ph+ ALL
  • Intolerant or resistant to imatinib mesylate
  • 18 years of age or older
  • ECOG performance 0-2 (greater than 50% of time out of bed)
  • Adequate liver and kidney function

Exclusion Criteria:

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A1
Drug: Dasatinib
Tablets, Oral, 70 mg, Twice daily, 2 months.
Other Names:
  • Sprycel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Provide therapy to patients for which there is no therapeutic alternative

Secondary Outcome Measures

Outcome Measure
Safety data collection

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

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

February 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

March 2, 2006

First Submitted That Met QC Criteria

March 3, 2006

First Posted (Estimate)

March 6, 2006

Study Record Updates

Last Update Posted (Estimate)

February 8, 2010

Last Update Submitted That Met QC Criteria

February 4, 2010

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA180-033

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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