Myeloproliferative Neoplasms Clinical Trial
Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Niltinib) Therapy
Summary
This study is being conducted in a population of patients with chronic phase leukemia-cml/" >Chronic Myeloid Leukemia (CML) to learn more about how patients follow prescribed regimens for taking oral cancer drugs.
Full Description
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.
Eligibility Criteria
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
Known performance status 0,1 or 2 (ECOG)
Known adequate end organ function, defined as:
Total bilirubin < 1.5 xULN SGOT and SGPT <2.5 x ULN ANC > 1.5 Platlets > 100,000
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
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There are 2 Locations for this study
Chicago Illinois, 60611, United States
Raleigh North Carolina, 27614, United States
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