Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Chronic Phase Chronic Myeloid Leukemia

Treatments: Drug: Dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01660906

2011-006180-21 (EudraCT Number)

CA180-400

Details and patient eligibility

About

This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from imatinib to dasatinib.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with CML-CP patients achieving an optimal response to imatinib treatment with Grade 1 or 2 non-hematologic adverse events persisting for at least 2 months or recurring at least 3 times in the preceding 12 months, despite best supportive care
• Men and women with Chronic Myeloid Leukemia- Chronic Phase (CML-CP) Ph+ ≥ age 18
• Daily Eastern Co-Operative Group (ECOG) performance status = 0 - 2
• Patient willing and able to give informed consent
• Life expectancy > 6 months
• Adequate renal function
• Adequate hepatic function

Exclusion criteria

• Patients who are pregnant or breast feeding
• Men whose partner is unwilling to avoid pregnancy.
• Previous treatment with any other tyrosine-kinase inhibitor (TKI), except for imatinib
• Current grade 3 or 4 imatinib related adverse event
• Prior documented T315I mutation
• Prior diagnosis of accelerated phase or blast crisis CML
• Previous loss of complete hematologic response (CHR) or major cytogenetic response (MCyR) on imatinib
• Concurrent medical condition of uncontrolled infection, cardiovascular diseases of cardiac failure, congenital long QT syndrome, ventricular arrhythmias, prolonged QT interval, second or third degree heart block, uncontrolled angina, myocardial infarction (MI) in the last 6 months, uncontrolled hypertension, pulmonary arterial hypertension, pleural or pericardial effusions, or history of bleeding disorder

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Dasatinib (100 mg)

Experimental group

Treatment:

Drug: Dasatinib