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

NCT01490775 | Terminated

• 1 other identifier: CAMN107AUS12T
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Phase CML

Keywords

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

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

  Patients are stratified to one of two groups: Group 1 is pateints 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

Study Arms (2)

eMedonline access

EXPERIMENTAL

patients will be followed for 3 months with access to eMedonline

Behavioral: eMedonline access

no access to eMedonline

ACTIVE COMPARATOR

patients will be followed for 3 months with no access to eMedonline

Behavioral: no access to eMedonline

Interventions

no access to eMedonline BEHAVIORAL

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

Also known as: Telemonitoring system, e-diary, electronic diary

no access to eMedonline

eMedonline access BEHAVIORAL

patients will be given access to eMedonline use for 3 months

Also known as: Telemonitoring system, e-diary, electronic diary

eMedonline access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent

Sponsors & Collaborators

• Rex Cancer Center, Raleigh, NC: lead
• Northwestern University: collaborator

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rex Cancer Center - Wakefield

Raleigh, North Carolina, 27614, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Wehbie, MD

  Rex Cancer Center - Wakefield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: December 13, 2011
• Study Start: April 1, 2009
• Primary Completion: February 12, 2015
• Study Completion: June 30, 2015
• Last Updated: August 13, 2018

Record last verified: 2017-04

Locations

US (2)