Efficacy and Safety of Nilotinib Patients With Newly Diagnosed CML - CP (Chronic Myelogenous Leukemia - Chronic Phase) (PHCHBS-WD4070)
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Extension Study to a Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
Study Start Date :
Estimated Primary Completion Date :
Estimated Study Completion Date :
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To compare the efficacy (MMR rate at 12 months) of nilotinib at 400mg/300mg BID with that of Gleevec/Glivec 400 mg QD in newly diagnosed, previously untreated Philadelphia chromosome-positive CML-CP patients. [ Time Frame: 12 months ]
Secondary Outcome Measures :
To compare the rate of durable MMR at 24 months, which is defined as the proportion of patients who have achieved MMR by 12 months, and also maintain continuous MMR until the 24 month timepoint. [ Time Frame: 24 months ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female patients ≥ 18 years of age.
ECOG 0, 1, or 2.
Patients with Ph+ CML who have failed treatment in the core protocol.
Diagnosis of chronic myelogenous leukemia with cytogenetic confirmation of Philadelphia chromosome of (9;22) translocations (presence of BCR-ABL a review of a minimum 20 metaphases is required).
Adequate end organ function as defined by:
Total bilirubin < 1.5 x ULN,
SGOT and SGPT < 2.5 x ULN,
Creatinine < 1.5 x ULN,
Serum amylase and lipase ≤ 1.5 x ULN,
Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related.
Patients must have the following laboratory values (≥ LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication.):
Potassium ≥ LLN,
Magnesium ≥ LLN,
Phosphorus ≥ LLN,
Total calcium (corrected for serum albumin) ≥ LLN.
Previously documented T315I mutations.
Impaired cardiac function including any one of the following:
LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by locally read echocardiogram.
Inability to determine the QT interval on ECG.
Complete left bundle branch block.
Use of a ventricular-paced pacemaker.
Congenital long QT syndrome or a known family history of long QT syndrome.
History of or presence of clinically significant ventricular or atrial tachyarrhythmias.