Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)

Stopped early · Phase 3

Conditions studied: Chronic Myeloid Leukemia

In brief

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.

Key facts

Study ID: NCT01650805
Run by: Ariad Pharmaceuticals
People needed: 307
Starts: 2012-06-01
Expected to finish: 2013-10-01
Last updated by the study team: 2014-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

UCLA Department of Medicine, Site #027 — Los Angeles, California, United States
Bay Area Cancer Research Group, Site #156 — Pleasant Hill, California, United States
Bay Area Cancer Research Group, Site #157 — Pleasant Hill, California, United States
Rocky Mountain Cancer Centers, Site #191 — Boulder, Colorado, United States
Cancer Center of Central Connecticut, Site #147 — Southington, Connecticut, United States
Christiana Care Health Services, Site #155 — Newark, Delaware, United States
University Cancer Institute, Site #149 — Boynton Beach, Florida, United States
Florida Cancer Specialists, Site #180 — Fort Meyers, Florida, United States
Florida Cancer Specialists, Site #179 — St. Petersburg, Florida, United States
Emory University, Site #058 — Atlanta, Georgia, United States
John H. Stroger, Jr. Hospital of Cook County, Site #192 — Chicago, Illinois, United States
University of Chicago, Site #001 — Chicago, Illinois, United States
Loyola University Chicago, Site #054 — Maywood, Illinois, United States
Franciscan St. Francis Health, Site #138 — Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Site #050 — Iowa City, Iowa, United States
Siouxland Hematology-Oncology Associates, Site #198 — Sioux City, Iowa, United States
US Oncology - Cancer Center of Kansas, Site #168 — Wichita, Kansas, United States
Willis-Knighton Cancer Center, Site #196 — Shreveport, Louisiana, United States
University of Maryland, Greenebaum Cancer Center, Site #040 — Baltimore, Maryland, United States
Greater Baltimore Medical Center, Site #140 — Baltimore, Maryland, United States
St. Agnes Healthcare, Site #185 — Baltimore, Maryland, United States
Massachusetts General Hospital, Site #047 — Boston, Massachusetts, United States
Dana Farber Cancer Institute, Site #008 — Boston, Massachusetts, United States
University of Massachusetts Worcester, Site #152 — Worcester, Massachusetts, United States
US Oncology - Providence Health System, Site #167 — Burbank, California, United States

Full record on ClinicalTrials.gov

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