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BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dasatinib
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Chronic-phase focused on measuring Chronic myelogenous leukemia (CML) chronic, accelerated, blast phase, Philadelphia chromosome positive acute (Ph+ALL)

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Establishment of MTD and recommended Phase II dose.

Secondary Outcome Measures

1) Hematologic Response 2) Cytogenetic Response.

Full Information

First Posted
February 14, 2005
Last Updated
April 13, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00103701
Brief Title
BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia
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 Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Chronic-phase, Leukemia, Lymphoblastic, Acute, Philadelphia-positive
Keywords
Chronic myelogenous leukemia (CML) chronic, accelerated, blast phase, Philadelphia chromosome positive acute (Ph+ALL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Intervention Description
Tablets, Oral, 15- 240 mg, Once or twice daily, 0-3 years depending on response.
Primary Outcome Measure Information:
Title
Establishment of MTD and recommended Phase II dose.
Secondary Outcome Measure Information:
Title
1) Hematologic Response 2) Cytogenetic Response.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Local Institution
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia

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