Chronic Phase CMLNCT01490775
Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Niltinib) Therapy
A study testing no access to eMedonline and eMedonline access in people with Chronic Phase CML, run by Rex Cancer Center, Raleigh, NC at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Phase CML
- What is being tested?
- no access to eMedonline and eMedonline access
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to 30 Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
Rex Cancer Center - Wakefield
Raleigh, North Carolina, 27614
About this study
Official title: Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib)Therapy
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.
Read the 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.
- Conditions
- Chronic Phase CML
- Being tested
- no access to eMedonline, eMedonline access
- Keywords
- Chronic Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no access to eMedonlineBehavioural
Also called Telemonitoring system, e-diary, electronic diary
patients will be followed for 3 months but will not use eMedonline
eMedonline accessBehavioural
Also called Telemonitoring system, e-diary, electronic diary
patients will be given access to eMedonline use for 3 months
| Study group | Role | What they receive |
|---|---|---|
| eMedonline access | Experimental | patients will be followed for 3 months with access to eMedonline Receives: Behavioral: eMedonline access |
| no access to eMedonline | Active comparator | patients will be followed for 3 months with no access to eMedonline Receives: Behavioral: no access to eMedonline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 6 months, non-compliance will be measured in each arm of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startApr 2009
- Primary completion12 Feb 2015
- Study completion30 Jun 2015
Why it stopped: Study was terminated due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Phase CMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rex Cancer Center, Raleigh, NC
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
- Investigators
- Robert Wehbie, MD, Principal investigator, Rex Cancer Center - Wakefield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490775
- Sponsor's protocol ID
- CAMN107AUS12T
- Status last verified
- Apr 2017
- First submitted
- 14 Oct 2011
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Telemonitoring of Gleevec (Imatinib Mesylate) or Tasigna (Nilotinib)Therapy
- ClinicalTrials.gov ID
- NCT01490775
- Acronym / sponsor ID
- CAMN107AUS12T
- Conditions
- Chronic Phase CML
- Keywords
- Chronic Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to lack of funding
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Rex Cancer Center, Raleigh, NCUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- Apr 2009
- Primary completion
- 12 Feb 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 13 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eMedonline access | Experimental | Behavioral: eMedonline accesspatients will be followed for 3 months with access to eMedonline |
| no access to eMedonline | Active comparator | Behavioral: no access to eMedonlinepatients will be followed for 3 months with no access to eMedonline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (1 listed)
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no access to eMedonlineAlso: Telemonitoring system, e-diary, electronic diarypatients will be followed for 3 months but will not use eMedonline | Behavioural | no access to eMedonline |
| eMedonline accessAlso: Telemonitoring system, e-diary, electronic diarypatients will be given access to eMedonline use for 3 months | Behavioural | eMedonline access |
Primary outcome
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
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.
Results and safety
The study was stopped early (reason given: Study was terminated due to lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wehbie, MD principal investigator
Rex Cancer Center - Wakefield
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing no access to eMedonline and eMedonline access in people with Chronic Phase CML, run by Rex Cancer Center, Raleigh, NC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was terminated due to lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.