Terminated due to lack of funding

This study is being conducted in a population of patients with chronic phase Chronic Myeloid Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral cancer drugs.

This is a randomized, controlled pilot study to introduce eMedonline telemonitoring technology to CML patients taking Gleevec or Tasigna. eMedonline will be used to automatically collect time-dose specific medication data for individual patients, including dosing times, missed doses, adverse events and e-diary data. All data will be available to research staff for remote review via Web interface. Adverse events and non-adherence will prompt interventions including supportive care counseling.

Inclusion Criteria:

• Patients 18 years of age or older.

• Pathologically documented diagnosis of Chronic Phase CML (Ph+) in whom treating physician has determined that treatment with imatinib or nilotinib is appropriate

• Patients currently receiving Gleevec (imatinib) 300-600 mg daily or Tasigna (nilotinib) 300-400 mg twice daily

• ECOG Performance status 0, 1, or 2

• Adequate end organ function, defined as:

  • Total bilirubin < 1.5 xULN
  • SGOT and SGPT <2.5 x ULN
  • Creatinine < 1.5 x ULN
  • ANC > 1.5
  • Platelets > 100,000

• Female patients of child bearing potential must have a negative urine or serum pregnancy test at screening.

• Patient is able to read and speak English

• Patient is willing and able to use a cell phone

• Written, voluntary informed consent

Exclusion Criteria:

• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent