Telemonitoring Study - for Chronic Myeloid Leukemia (CML)

Chronic Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01490983
• Other study ID #: RexCCWF1
• Status: Terminated
• Phase: N/A
• Start date: April 2009
• Est. completion date: December 2014

Study information

• Verified date: April 2016
• Source: Rex Cancer Center, Raleigh, NC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• no access to eMedonline
patients will be followed for 3 months but will not use eMedonline
• eMedonline access
patients will be given access to eMedonline use for 3 months

Locations

Country	Name	City	State
United States	UNC Healthcare	Chapel Hill	North Carolina
United States	Rex Cancer Center	Raleigh	North Carolina
United States	Rex Cancer Center - Wakefield	Raleigh	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Rex Cancer Center, Raleigh, NC	Leap of Faith Technologies, Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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