A Safety and Efficacy Study of Adding Low Dose Pegylated IFN-alpha 2B to Standard Dose Dasatinib in Patients With Newly Diagnosed Chronic Phase Myeloid Leukemia
Inclusion Criteria:
- Diagnosis of chronic myeloid leukemia in chronic phase (CML-CP) associated with
BCR-ABL1 quantifiable by RQ-PCR (IS)
- No other current or planned anti-leukemia therapies excluding hydroxyurea treatment
for up to two months.
- ECOG Performance status 0,1, or 2
- Adequate organ function as defined by: Total bilirubin < 1.5 x ULN (ULN = upper limit
of normal in a local institution lab) in absence of Gilbert genotype; ASAT and ALAT <
2.5 x ULN. Creatinine < 2x ULN. Potassium, magnesium and phosphate not below LLN
(LLN= lower level of normal)
- Life expectancy of more than 12 months in the absence of any intervention
- Patient has given written informed consent to participate in the study
Exclusion Criteria:
- Prior accelerated phase or blast crisis
- Uncontrolled or significant cardiovascular disease, including any of the following:
- A myocardial infarction within 6 months
- Uncontrolled angina within 3 months
- Congestive heart failure within 3 months
- Diagnosed or suspected congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as
ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe)
- Prolonged QTcF interval > 450 msec on pre-entry ECG
- Atypical BCR-ABL1 transcript not quantifiable by RQ-PCR.
- Another primary malignant disease, which requires systemic treatment (chemotherapy or
radiation) Severe and/or life-threatening medical disease including acute liver
disease
- History of significant congenital or acquired bleeding disorder unrelated to cancer
- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of dasatinib
- Patients actively receiving therapy with strong CYP3A4 inhibitors and the treatment
cannot be either discontinued or switched to a different medication prior to starting
study drug
- Patients who are currently receiving treatment with any medications that have the
potential to prolong the QT interval and the treatment cannot be either discontinued
or switched to a different medication prior to starting study drug
- Female patients who are: pregnant, breast feeding or potentially fertile without a
negative pregnancy test prior to baseline or unwilling to use contraception on trial
- Previous history of pericarditis or pleuritis
- History of non-compliance, abuse of alcohol, illicit drugs, severe psychiatric
disorders or other inability to grant informed consent.
- Current treatment for depression.
- Hypersensitivity to any interferon preparation;
- Autoimmune hepatitis or a history of autoimmune disease;
- Pre-existing thyroid disease unless it can be controlled with conventional treatment;
- Epilepsy and/or compromised central nervous system (CNS) function;
- HCV/HIV patients