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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Leukemia, Myeloid, Chronic; Leukemia, Lymphocytic, Acute, L2

Treatments: Drug: Dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00298987

CA180-033

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

A1

Experimental group

Treatment:

Drug: Dasatinib