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Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib) Therapy


N/A
18 Years
N/A
Open (Enrolling)
Both
Chronic Myeloid Leukemia

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Trial Information

Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib) Therapy


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

- 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

- Creatinine < 1.5 x ULN

- ANC > 1.5

- Platelets > 100,000

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

eMedonline will be used to measure non-compliance in taking oral drug regimens.

Outcome Description:

Patients are stratified to one of two groups: Group 1 is patients on Gleevec or Tasigna who have been on drug less than 6 months; Group 2 is patients on Gleevec or Tasigna who have been on drug for equal to or more than 6 months. Group 1 is then divided into 2 groups: one using eMedonline for 3 months and the other not using eMedonline for 3 months. A crossover survey and pill counts will be done at the 3 month timepoint and then the groups will switch their access status to eMedonline.

Outcome Time Frame:

at 6 months, non-compliance will be measured in each arm of study

Safety Issue:

No

Principal Investigator

Robert Wehbie, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rex Cancer Center - Wakefield

Authority:

United States: Institutional Review Board

Study ID:

RexCCWF1

NCT ID:

NCT01490983

Start Date:

April 2009

Completion Date:

December 2014

Related Keywords:

  • Chronic Myeloid Leukemia
  • Chronic Myeloid Leukemia
  • Chronic Phase CML
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Rex Cancer CenterRaleigh, North Carolina  27607
Rex Cancer Center - WakefieldRaleigh, North Carolina  27614
UNC HealthcareChapel Hill, North Carolina  27599