Telemonitoring Study - for Chronic Myeloid Leukemia (CML)
Status: | Terminated |
---|---|
Conditions: | Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/15/2018 |
Start Date: | April 2009 |
End Date: | December 2014 |
Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib) Therapy
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.
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.
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
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3
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