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

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).

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Key information

Conditions

Leukemia, Myeloid, Chronic-Phase Blast Crisis Bone Marrow Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Carcinogenesis Cell Transformation, Neoplastic Chronic Disease Disease Attributes Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoblastic, Acute, Philadelphia-Positive Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Lung Diseases Lung Diseases, Obstructive Lymphatic Diseases Lymphoproliferative Disorders Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplastic Processes Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Respiratory Tract Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dasatinib

Drug

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

Other names: Sprycel

Primary outcomes

Establishment of MTD and recommended Phase II dose.

Secondary outcomes

1) Hematologic Response 2) Cytogenetic Response.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2006
Study completion: 2006
First posted: Feb 15, 2005
Registry last updated: Apr 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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