Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
