Safety and Efficacy of Pegylated IFN-alpha 2B Added to Dasatinib in Newly Diagnosed Chronic Phase Myeloid Leukemia (NordCML007)

This is an interventional treatment trial for Leukemia, Myeloid, Chronic-Phase focused on measuring dasatinib, Protein Kinase Inhibitors, pegylated IFN-alpha 2B, Interferon-alpha Read More

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