Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML

Inclusion Criteria

• Body surface area >= 1 m^2
• Allogeneic HCT
• Acute lymphocytic leukemia (ALL) or chronic myelogenous leukemia (CML) characterized by the p190 and/or p210 BCR/ABL gene rearrangement
• CML in accelerated phase, blast crisis, or blast crisis remission as defined by World Health Organization (WHO) criteria
• CML in chronic phase if patient age = 20 x 10^9 /L
• Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) = = lower limit normal (LLN) or correctable with supplements prior to first dose of study drug; calcium levels may be corrected for hypoalbuminemia
• Serum amylase and lipase 17 years with CML in first chronic phase
• Aberrant antigen expression on marrow leukemic blasts >= 5% by multidimensional flow cytometric assay immediately before conditioning (CML patients in chronic phase exempt from flow cytometry screening)
• Ph+ ALL without complete cytogenetic remission immediately before conditioning
• Known T315I mutation
• Hypersensitivity to Gleevec or Tasigna
• Patients who are Tasigna-resistant or intolerant
• Central nervous system (CNS) involvement with leukemia at baseline (pre-imatinib therapy); CML chronic phase (CP), accelerated phase (AP) patients exempt from CNS involvement screening
• Female patients who are pregnant, breast-feeding, or of childbearing potential without a negative serum pregnancy test at screening; male or female patients of childbearing potential unwilling to use effective contraceptive precautions throughout the trial; post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
• Life expectancy severely limited by diseases other than leukemia
• Myocardial infarction within one year prior to starting nilotinib
• Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, unstable angina)
• Absolute neutrophil count (ANC) less than 1500 per microliter at study entry despite the use of filgrastim (G-CSF)
• Impaired cardiac function, including any one of the following:
• Complete left bundle branch block or bifascicular block (right bundle branch block plus left anterior hemiblock) or use of ventricular-paced pacemaker
• Congenital long QT syndrome or a family history of long QT syndrome
• History of or presence of significant ventricular or atrial tachyarrhythmias
• Clinically significant resting bradycardia ( 450 milliseconds on screening electrocardiogram (ECG); if QTc > 450 and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient rescreened for QTc