This trial is active, not recruiting.

Condition chronic phase cml
Treatments no access to emedonline, emedonline access
Sponsor Rex Cancer Center, Raleigh, NC
Collaborator Northwestern University
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose supportive care
emedonline access Telemonitoring system
patients will be given access to eMedonline use for 3 months
patients will be followed for 3 months with no access to eMedonline
no access to emedonline Telemonitoring system
patients will be followed for 3 months but will not use eMedonline

Primary Outcomes

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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Rex Cancer Center, Raleigh, NC.