Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia (CML0408)

This is an interventional treatment trial for Leukemia focused on measuring chronic myelogenous leukemia, BCR-ABL1 positive, chronic phase chronic myelogenous leukemia Read More

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