Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
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This study is designed to investigate the molecular and cytogenetic effects and safety profile of nilotinib in the treatment of early chronic phase of Ph+ CML among different risk groups of patients and to compare patients with high Socal risk score with patients having intermediate and low Socal risk score.
A Phase II Multi-center, Open-label, Non-randomized Study of Nilotinib as First Line Treatment in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Actual Study Start Date
January 25, 2011
Estimated Primary Completion Date
December 31, 2017
Estimated Study Completion Date
December 31, 2017
Resource links provided by the National Library of Medicine
Rate of major molecular response (MMR) by 12 months and comparison of major molecular response (MMR) rates by 12 months between high sokal risk patients and low&intermediate sokal risk patients [ Time Frame: 3 monthly intervals until 12 month ]
Secondary Outcome Measures
Rate of complete cytogenetic response (CCyR) by 6 and 12 months [ Time Frame: 6 and 12 months ]
Rate of molecular response at 3 monthly basis [ Time Frame: 3 monthly intervals ]
Rate of hematologic response [ Time Frame: 3 monthly intervals ]
Number of patients with adverse events [ Time Frame: Every visit ]
Time and duration of major molecular response (MMR) [ Time Frame: 3 monthly intervals ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
First cytogenetic diagnosis of CML-CP with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations within 6 months. Standard conventional cytogenetic analysis must be performed.
Previously untreated for CML, except for hydroxyurea and/or anagrelide (except imatinib treatment for max. 31 days long)
Adequate end organ function with following laboratory criteria: total bilirubin < 1.5 x upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN); creatinine < 1.5 x upper limit of normal (ULN); serum amylase and lipase ≤ 1.5 x upper limit of normal (ULN); alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN) unless considered tumor related
Serum potassium, magnesium, and phosphorus levels are equal or above the lower limit of normal prior to the first dose of study medication
Treatment with tyrosine kinase inhibitor(s) prior to study (in emergent cases where the patient requires disease management while awaiting study start, commercial supplies of imatinib at any dose may be prescribed to the patient but for no longer than 31 days in duration)
Known cytopathologically confirmed Central Nervous System CNS infiltration
Impaired cardiac function
Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection)
Acute or chronic liver, pancreatic or severe renal disease considered unrelated to disease
Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
History of significant congenital or acquired bleeding disorder unrelated to cancer
Previous radiotherapy to ≥25% of the bone marrow
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery)
Use of therapeutic coumarin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
Patients actively receiving therapy with 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
Other protocol-defined inclusion/exclusion criteria may apply