A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate

Bristol-Myers Squibb400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Leukemia, Myeloid, Chronic Leukemia, Lymphocytic, Acute, L2

Interventions

DasatinibDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of accelerated phase or blast phase CML or Ph+ ALL * Intolerant or resistant to imatinib mesylate * 18 years of age or older * ECOG performance 0-2 (greater than 50% of time out of bed) * Adequate liver and kidney function Exclusion Criteria: * Pregnant or breastfeeding females * History of significant cardiac disease * History of significant bleeding disorder (not CML) * Prisoners

Locations (35)

Outcomes

Primary Outcomes

Provide therapy to patients for which there is no therapeutic alternative

Secondary Outcomes

Safety data collection

Data from ClinicalTrials.gov

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Local Institution

Corona, California, United States

Local Institution

Aurora, Colorado, United States

Local Institution

Colorado Springs, Colorado, United States

Local Institution

Waterford, Connecticut, United States

Local Institution

Daytona Beach, Florida, United States

Local Institution

Jupiter, Florida, United States

Local Institution

Atlanta, Georgia, United States

Local Institution

Lawrenceville, Georgia, United States

Local Institution

Beach Grove, Indiana, United States

Local Institution

Indianapolis, Indiana, United States

...and 25 more locations