Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Niltinib) Therapy
This trial is active, not recruiting.
|Condition||chronic phase cml|
|Treatments||no access to emedonline, emedonline access|
|Sponsor||Rex Cancer Center, Raleigh, NC|
|Start date||April 2009|
|End date||December 2014|
|Trial size||48 participants|
|Trial identifier||NCT01490775, CAMN107AUS12T|
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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Primary purpose||supportive care|
eMedonline will be used to measure non-compliance in taking oral drug regimens.
time frame: at 6 months, non-compliance will be measured in each arm of study
Male or female participants at least 18 years old.
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
|Official title||Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib)Therapy|
|Principal investigator||Robert Wehbie, MD|
|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.|
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