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.

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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.

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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

Study is for people with:

Myeloproliferative Neoplasms

Estimated Enrollment:

27

Study ID:

NCT01490775

Recruitment Status:

Terminated

Sponsor:

Rex Cancer Center, Raleigh, NC

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There are 2 Locations for this study

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Northwestern University
Chicago Illinois, 60611, United States
Rex Cancer Center - Wakefield
Raleigh North Carolina, 27614, United States

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Study is for people with:

Myeloproliferative Neoplasms

Estimated Enrollment:

27

Study ID:

NCT01490775

Recruitment Status:

Terminated

Sponsor:


Rex Cancer Center, Raleigh, NC

How clear is this clinincal trial information?

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