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

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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.

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
We found this trial at
3
sites
Raleigh, North Carolina 27609
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Raleigh, NC
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Raleigh, North Carolina 27614
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Raleigh, NC
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