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

Phase 1

Completed

• Conditions: Leukemia, Myeloid, Chronic-phase; Leukemia, Lymphoblastic, Acute, Philadelphia-positive
• Interventions: Drug: Dasatinib

• Registration Number: NCT00103701
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-02-14
• Study First Submitted QC: 2005-02-14
• Study First Posted: 2005-02-15
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Dasatinib	-

Primary Outcome Measures

Name	Time	Method
Establishment of MTD and recommended Phase II dose.

Secondary Outcome Measures

Name	Time	Method
1) Hematologic Response 2) Cytogenetic Response.

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Houston, Texas, United States