Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC) | NCT01650805 | Trialant

Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC) | NCT01650805 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

CP CML within 6 months of diagnosis

CP-CML will be defined by (i) <15% blasts in bone marrow; (ii) <30% blasts plus promyelocytes in bone marrow; (iii) <20% basophils in peripheral blood; (iv) ≥100 × 10^9/L platelets (≥100,000/mm^3); (v) No evidence of extramedullary disease except hepatosplenomegaly; AND (vi) No prior diagnosis of AP-CML or BP-CML

Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22) Philadelphia chromosome

(a)Variant translocations are only allowed provided they are assessable for cytogenetic response utilizing conventional cytogenetic techniques; (b) Conventional chromosome banding must be performed; AND (c) A minimum of 20 metaphases must be assessable at entry

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Adequate hepatic function as defined by the following criteria:

(a) Total serum bilirubin ≤1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome; (b) Alanine aminotransferase (ALT) ≤2.5 × ULN; AND (c) Aspartate aminotransferase (AST) ≤2.5 × ULN

Adequate renal function as defined as defined by serum creatinine <1.5 x ULN

Adequate pancreatic function as defined by serum lipase and amylase ≤1.5 × ULN

Exclusion Criteria:

Received prior imatinib therapy

Received prior dasatinib therapy

Received prior nilotinib therapy

Received, for CML, any other systemic anticancer therapy, experimental therapy, or radiation therapy with the exception of anagrelide or hydroxyurea

Major surgery within 28 days prior to initiating therapy

History of bleeding disorder unrelated to CML

History of acute pancreatitis within 1 year of study or history of chronic pancreatitis

History of alcohol abuse

Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)

Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:

Myocardial infarction, within 6 months prior to randomization

Unstable angina within 6 months prior to randomization

Congestive heart failure within 6 months prior to randomization

History of clinically significant (as determined by the treating physician) atrial arrhythmia or any ventricular arrhythmia

Any history of ventricular arrhythmia

Cerebrovascular accident or transient ischemic attack within 6 months prior to randomization

Any history of peripheral arterial occlusive disease requiring revascularization

Any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism

Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control

Taking medications that are known to be associated with Torsades de Pointes

Ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection

Known history of human immunodeficiency virus (HIV). Testing is not required in the absence of history

Pregnant or breastfeeding

Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of study drugs

Diagnosed with or received anticancer therapy for another primary malignancy within 3 years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ)

Any condition or illness that, in the opinion of the Investigator, would compromise patient safety or interfere with the evaluation of the drug