Telemonitoring Study - for Chronic Myeloid Leukemia (CML)

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01490983

Enrollment

Registered

2011-12-13

Start date

2009-04-30

Completion date

2014-12-31

Last updated

2018-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic Myeloid Leukemia, Chronic Phase CML

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 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.

Interventions

BEHAVIORALno access to eMedonline

patients will be followed for 3 months but will not use eMedonline

BEHAVIORALeMedonline access

patients will be given access to eMedonline use for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
eMedonline will be used to measure non-compliance in taking oral drug regimens.	at 6 months, non-compliance will be measured in each arm of study	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026