Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia

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