Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)
Status: Recruiting
Phase: Phase 3
Diagnosis: Leukemia/MDS
NCT ID: NCT01650805
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-426
The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.
Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital
Overall PI:
Martha Wadleigh, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Ilene Galinsky, 617-632-3902,
igalinsky@partners.org
Eligibility Criteria
Inclusion Criteria:
1. 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
2. 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
3. ECOG Performance Status of 0, 1, or 2
4. 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
5. Adequate renal function as defined as defined by serum creatinine <1.5 x ULN
6. Adequate pancreatic function as defined by serum lipase and amylase ≤1.5 × ULN
Exclusion Criteria:
1. Received prior imatinib therapy
2. Received prior dasatinib therapy
3. Received prior nilotinib therapy
4. Received, for CML, any other systemic anticancer therapy, experimental therapy, or
radiation therapy with the exception of anagrelide or hydroxyurea
5. Major surgery within 28 days prior to initiating therapy
6. History of bleeding disorder unrelated to CML
7. History of acute pancreatitis within 1 year of study or history of chronic
pancreatitis
8. History of alcohol abuse
9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
10. Significant uncontrolled or active cardiovascular disease, specifically including,
but not restricted to:
(a) Myocardial infarction, unstable angina and/or congestive heart failure within 3
months prior to randomization; OR (b) History of clinically significant (as
determined by the treating physician) atrial arrhythmia or any ventricular arrhythmia
11. Uncontrolled hypertension (diastolic blood pressure >100 mm Hg; systolic >150 mm Hg)
12. Taking medications that are known to be associated with Torsades de Pointes
13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics is
considered active infection
14. Known history of human immunodeficiency virus (HIV). Testing is not required in the
absence of history
15. Pregnant or breastfeeding
16. Malabsorption syndrome or other gastrointestinal illness that could affect oral
absorption of study drugs
17. 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)
18. Any condition or illness that, in the opinion of the Investigator, would compromise
patient safety or interfere with the evaluation of the drug