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Leukemia

Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (2645)
A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Status Conditions Phase Study ID
Closed Chronic Myeloid Leukemia Phase III 2645
NCT01650805
Summary

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.


Investigator
Vivian Oehler, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  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
Exclusions (conditions that would prevent participation in this study)
  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
Last Updated
May 12, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.