NCT00103701

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).

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 2003

Typical duration for phase_1

Geographic Reach
1 country

2 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

November 1, 2003

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

April 14, 2011

Status Verified

April 1, 2011

Enrollment Period

2.3 years

First QC Date

February 14, 2005

Last Update Submit

April 13, 2011

Conditions

Leukemia, Myeloid, Chronic-phaseLeukemia, Lymphoblastic, Acute, Philadelphia-positive

Keywords

Chronic myelogenous leukemia (CML) chronic, accelerated, blast phasePhiladelphia chromosome positive acute (Ph+ALL)

Outcome Measures

Primary Outcomes (1)

  • Establishment of MTD and recommended Phase II dose.

Secondary Outcomes (1)

  • 1) Hematologic Response 2) Cytogenetic Response.

Study Arms (1)

1

EXPERIMENTAL
Drug: Dasatinib

Interventions

DasatinibDRUG

Tablets, Oral, 15- 240 mg, Once or twice daily, 0-3 years depending on response.

Also known as: Sprycel
1

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution

Los Angeles, California, United States

Location

Local Institution

Houston, Texas, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-PhasePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myelogenous, Chronic, BCR-ABL PositiveBronchiolitis Obliterans SyndromeBlast Crisis

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseCell 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 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 14, 2005

First Posted

February 15, 2005

Study Start

November 1, 2003

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

April 14, 2011

Record last verified: 2011-04

Locations

US(2)