Chronic Myeloid LeukemiaNCT01394666
Non-interventional Treatment Patterns Study in Chronic Phase Chronic Myelogenous Leukemia (CP-CML)
An observational study of Chronic Myeloid Leukemia, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to evaluate treatment patterns and associated outcomes for CP-CML patients who fail Imatinib 400 mg daily in a real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Dec 2012
- Phase
- Observational
- 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
Study population: Primary care clinic, academic and community oncology centers
Who may be able to join
- Adult patients (18 years or older) in Chronic phase CML patients who have been treated with Imatinib 400 mg and have failed.
Who cannot join
None listed.
About this study
Official title: Treatment Patterns and Associated Outcomes in Chronic Phase (CP) Chronic Myelogenous Leukemia (CML) Patients Who Fail Imatinib 400 mg Daily
The purpose of this study is to evaluate treatment patterns and associated outcomes for CP-CML patients who fail Imatinib 400 mg daily in a real-world setting.
Read the detailed description
Time Perspective: Retrospective and Prospective
- Conditions
- Chronic Myeloid Leukemia
- Medical subject headings
- 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.
| Study group | Role | What they receive |
|---|---|---|
| CP-CML patients who have failed Imatinib 400 mg daily | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily
Measured: At 3 months post treatment change
Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily
Measured: At 6 months post treatment change
Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily
Measured: At 12 months post treatment change
Secondary outcomes (8)
Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily
Measured: Baseline
Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily
Measured: 3 months after start of treatment
Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily
Measured: 6 months after start of treatment
Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily
Measured: 12 months after start of treatment
Best response rates achieved by patients if no CCyR
Measured: Baseline
Best response rates achieved by patients if no CCyR
Measured: 3 months after start of treatment
Best response rates achieved by patients if no CCyR
Measured: 6 months after start of treatment
Best response rates achieved by patients if no CCyR
Measured: 12 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394666
- Sponsor's protocol ID
- CA180-240
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2011
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns and Associated Outcomes in Chronic Phase (CP) Chronic Myelogenous Leukemia (CML) Patients Who Fail Imatinib 400 mg Daily
- ClinicalTrials.gov ID
- NCT01394666
- Acronym / sponsor ID
- CA180-240
- Conditions
- Chronic Myeloid Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Jul 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.
The purpose of this study is to evaluate treatment patterns and associated outcomes for CP-CML patients who fail Imatinib 400 mg daily in a real-world setting.
Detailed description
Time Perspective: Retrospective and Prospective
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CP-CML patients who have failed Imatinib 400 mg daily | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic, academic and community oncology centers
Key inclusion criteria (1 listed)
- Adult patients (18 years or older) in Chronic phase CML patients who have been treated with Imatinib 400 mg and have failed.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily
Time frame: At 3 months post treatment change
Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily
Time frame: At 6 months post treatment change
Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily
Time frame: At 12 months post treatment change
8 secondary outcomes
Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily
Time frame: Baseline
Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily
Time frame: 3 months after start of treatment
Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily
Time frame: 6 months after start of treatment
Prognostic factors (clinical and demographic characteristics) that influence treatment selection for CP-CML patients who fail imatinib 400 mg daily
Time frame: 12 months after start of treatment
Best response rates achieved by patients if no CCyR
Time frame: Baseline
Best response rates achieved by patients if no CCyR
Time frame: 3 months after start of treatment
Best response rates achieved by patients if no CCyR
Time frame: 6 months after start of treatment
Best response rates achieved by patients if no CCyR
Time frame: 12 months after start of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htmLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia, run by Bristol-Myers Squibb.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete Cytogenic Response (CCyR) for CP-CML patients who failed Imatinib 400 mg daily (time frame: At 3 months post treatment change). The study lists 3 primary outcomes in all. 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 11 Jul 2016.