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This study evaluates the drugs Nilotinib and Imatinib Mesylate in patients with early chronic phase Chronic Myelogenous Leukemia (CML). It included Philadelphia chromosome-positive, BCR-ABL-positive patients within 6 months of diagnosis. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
DISEASE CHARACTERISTICS: * Cytologically and cytogenetically confirmed chronic myelogenous leukemia meeting the following criteria: * Early chronic phase disease (\< 6 months from diagnosis) * Philadelphia chromosome-positive disease * BCR-ABL-positive PATIENT CHARACTERISTICS: * WHO performance status 0-1 * ALT and AST = 2.5 times upper limit of normal (ULN) (5.0 times ULN if considered due to leukemia) * Alkaline phosphatase = 2.5 times ULN (unless considered due to leukemia) * Serum bilirubin = 1.5 times ULN * Serum creatinine = 1.5 times ULN * Serum amylase = 1.5 times ULN * Serum lipase = 1.5 times ULN * Normal serum levels of the following or correctable with supplements: * Potassium * Total calcium (corrected for serum albumin) * Magnesium * Phosphorus * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier method contraception during study and for up to 3 months following completion of study treatment * No impaired cardiac function, including any of the following: * LVEF \< 45% by MUGA scan or echocardiogram * Uncontrolled congestive heart failure * Uncontrolled hypertension * Uncontrolled angina pectoris * Myocardial infarction within the past 12 months * No significant electric heart abnormalities, including any of the following: * History or active ventricular or atrial tachyarrhythmias * Congenital long QT syndrome and/or QTc \> 450 msec on screening ECG * No history of acute (within one year) or chronic pancreatitis * No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) * No acute or chronic liver or renal disease considered unrelated to leukemia * No known diagnosis of HIV infection * No other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol * No other primary malignancy that is currently clinically significant or requires active intervention PRIOR CONCURRENT THERAPY: * More than 2 weeks since prior major surgery and recovered * More than 30 days since prior imatinib mesylate, with a washout period of ≥ 7 days * More than 4 weeks since prior investigational drug * No prior hematopoietic stem cell transplantation * No concurrent therapeutic coumarin derivates (i.e., warfarin, acenocoumarol, phenprocoumon) * No concurrent medications that would prolong the QT interval * No concurrent chemotherapy, investigational agents, radiotherapy, or biologic therapy * Prior treatment with hydroxyurea or anagrelide allowed