Status:
TERMINATED
Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Niltinib) Therapy
Lead Sponsor:
Rex Cancer Center, Raleigh, NC
Collaborating Sponsors:
Northwestern University
Conditions:
Chronic Phase CML
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed 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 spe...
Eligibility Criteria
Inclusion
- 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
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01490775
Start Date
April 1 2009
End Date
June 30 2015
Last Update
August 13 2018
Active Locations (2)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Rex Cancer Center - Wakefield
Raleigh, North Carolina, United States, 27614