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

Phase 2

Completed

• Conditions: Leukemia, Myeloid, Chronic; Leukemia, Lymphocytic, Acute, L2
• Interventions: Drug: Dasatinib

• Registration Number: NCT00298987
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-03-02
• Study First Submitted QC: 2006-03-03
• Study First Posted: 2006-03-06
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2008-06
• Disposition First Submitted: 2010-02-04
• Disposition First Submitted QC: 2010-02-04
• Last Update Submitted: 2010-02-04
• Disposition First Posted: 2010-02-08
• Last Update Posted: 2010-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A1	Dasatinib	-

Primary Outcome Measures

Name	Time	Method
Provide therapy to patients for which there is no therapeutic alternative

Secondary Outcome Measures

Name	Time	Method
Safety data collection

Trial Locations

Locations (1)

Local Institution; 🇨🇦 Montreal, Quebec, Canada