NCT00298987

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

Geographic Reach
2 countries

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 8, 2010

Status Verified

June 1, 2008

Enrollment Period

1.3 years

First QC Date

March 2, 2006

Last Update Submit

February 4, 2010

Conditions

Leukemia, Myeloid, ChronicLeukemia, Lymphocytic, Acute, L2

Keywords

Chronic Myeloid Leukemia Accelerated and Blast PhaseLeukemia, Acute, Philadelphia-Positive

Outcome Measures

Primary Outcomes (1)

  • Provide therapy to patients for which there is no therapeutic alternative

Secondary Outcomes (1)

  • Safety data collection

Study Arms (1)

A1

EXPERIMENTAL
Drug: Dasatinib

Interventions

DasatinibDRUG

Tablets, Oral, 70 mg, Twice daily, 2 months.

Also known as: Sprycel
A1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Local Institution

Corona, California, United States

Location

Local Institution

Aurora, Colorado, United States

Location

Local Institution

Colorado Springs, Colorado, United States

Location

Local Institution

Waterford, Connecticut, United States

Location

Local Institution

Daytona Beach, Florida, United States

Location

Local Institution

Jupiter, Florida, United States

Location

Local Institution

Atlanta, Georgia, United States

Location

Local Institution

Lawrenceville, Georgia, United States

Location

Local Institution

Beach Grove, Indiana, United States

Location

Local Institution

Indianapolis, Indiana, United States

Location

Local Institution

Iowa City, Iowa, United States

Location

Local Institution

Kansas City, Kansas, United States

Location

Local Institution

Salina, Kansas, United States

Location

Local Institution

Lexington, Kentucky, United States

Location

Local Institution

Louisville, Kentucky, United States

Location

Local Institution

Boston, Massachusetts, United States

Location

Local Institution

Ann Arbor, Michigan, United States

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Local Institution

Detroit, Michigan, United States

Location

Local Institution

Santa Fe, New Mexico, United States

Location

Local Institution

New York, New York, United States

Location

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Cincinnati, Ohio, United States

Location

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Cleveland, Ohio, United States

Location

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Lawton, Oklahoma, United States

Location

Local Institution

Tulsa, Oklahoma, United States

Location

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Portland, Oregon, United States

Location

Local Institution

Providence, Rhode Island, United States

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Local Institution

Charleston, South Carolina, United States

Location

Local Institution

Chattanooga, Tennessee, United States

Location

Local Institution

Spokane, Washington, United States

Location

Local Institution

Sheboygan, Wisconsin, United States

Location

Local Institution

Edmonton, Alberta, Canada

Location

Local Institution

Vancouver, British Columbia, Canada

Location

Local Institution

Hamilton, Ontario, Canada

Location

Local Institution

Toronto, Ontario, Canada

Location

Local Institution

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositivePrecursor Cell Lymphoblastic Leukemia-LymphomaBlast CrisisLeukemia

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCell Transformation, NeoplasticCarcinogenesisNeoplastic Processes

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 2, 2006

First Posted

March 6, 2006

Study Start

February 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 8, 2010

Record last verified: 2008-06

Locations

CA(5)US(30)