Leukemia, Myeloid, Chronic-Phase (CML-CP)NCT01188278
Treatment With Second Generation Tyrosine Kinase Inhibitors (2G TKI) Post Imatinib Failure Survey
An observational study of Leukemia, Myeloid, Chronic-Phase (CML-CP), run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Chronic-Phase (CML-CP)
- What is being tested?
- Imatinib
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jan 2013
- 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: Hematology centers (hospitals) which have necessary historical data available
Who may be able to join
- Patients diagnosed with CP-CML. (ACA) are allowed
- Age >18 years old
- Prior treatment with imatinib monotherapy as first line treatment, to which the patient is deemed resistant or intolerant.Patients treated by INF and/or AraC prior (but not concomitant) to imatinib are eligible.
- Initiated with a 2G TKIs post-imatinib failure (resistance or intolerance) between 1-Jan-2005 and 30-Jun-2009.
Who cannot join
- Patients in (or with history of) accelerated or blastic phase CML
- Patients treated by allogeneic stem cell transplantation.
- Any other CML treatment except for INF and/or AraC,and a short period of Hydroxyurea or Anagrelide prior to imatinib.
- Patients treated with 2G TKI for reasons other than imatinib failure.
- Patients with no historical data (e.g. possibility of Sokal Score calculation) available.
- Patients participating in clinical or observational trials which explicitly prohibit enrollment in non interventional studies.
About this study
Official title: Treatment With Second Generation TYROSINE KINASE INHIBITORS (2G TKI) Post Imatinib Failure: Factors Predicting Response and Predictive Value of Response
The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR).
Read the detailed description
Historic cohort prolonged by a 12-month follow-up period.
Prospective: look forward using periodic observations collected predominantly following subject enrollment: one year of follow up of patients with CP-CML alive at the time of the study.
Retrospective: look back using observations collected predominantly prior to subject selection and enrollment : historical data of patients with CP-CML initiated with a 2G TKIs post-imatinib failure (resistance or intolerance) between 1-Jan-2005 and 30-June-2009.
The inclusion of a historical cohort will allow a rapid enrollment of a large number of patients of this rare pathology, while the prospective follow up of this cohort would allow long term data to be obtained, including the assessment of the impact on survival and appreciate the patient's quality of life (QoL), compliance and satisfaction.
- Being tested
- Imatinib
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Also called Dasatinib, Nilotinob
Drug being observed but not provided
| Study group | Role | What they receive |
|---|---|---|
| Patients in CP-CML treated with 2G TKI | Patients in CP-CML treated with 2G TKI (nilotinib or dasatinib) post imatinib failure Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR)
The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR), as assessed by the following:
- Distribution of patients according to Hammersmith score levels
- Characterization of association between Hammersmith score and occurrence of CCyR
- Assessment of capacity of Hammersmith score to predict CCyR, using diagnostic test assessment methods.
This score is measured at the time of imatinib failure.
Measured: CCyR at 6 month of 2GTKI treatment
Secondary outcomes (5)
Predictive value of Hammersmith score on Major Molecular Response (MMR)
The purpose of this study is to determine predictive value of Hammersmith score on Major Molecular Response(MMR), as assessed by the following:
- Distribution of patients according to Hammersmith score levels
- Characterization of association between Hammersmith score and occurrence of MMR
- Assessment of capacity of Hammersmith score to predict MMR, using diagnostic test assessment methods.
This score is measured at the time of imatinib failure.
Measured: MMR at 3 month of 2GTKI treatment
Predictive factors of Overall survival (including Hammersmith score, MMR at 3 months and CCyR at 6 months of 2G TKI treatment together with patients, disease and treatment characteristics)
Measured: From switch to 2G TKI between 01Jan2005 and 30Jun2009 to 31Oct2011 if alive or to the death
Predictive value of Hammersmith score compared to other factors
imatinib treatment duration, mutations at time of failure, best response to imatinib, time between imatinib failure \& initiation of 2G TKI on the response to 2G TKI \& on the survival end points (Overall Survival (OS)\& Progression Free Survival (PFS)).
Measured: From switch to 2G TKI between 01Jan2005 and 30Jun2009 to 31Oct2011 if alive or to the death
Patients populations (socio-demographic data, medical history, disease history, co morbidities treated with 2G TKI
Measured: When occurs the switch from Imatinib to 2G TKI between 01Jan2005 and 30Jun2009
Patients' satisfaction, Quality of life & compliance to treatment in patients treated with 2G TKIs
Measured: For all alive patients treated with 2G TKI during the enrolment period (Jun2010 to Oct2010)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, Chronic-Phase (CML-CP)Studies 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
- Prospective
- Enrolment
- 173 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
- NCT01188278
- Sponsor's protocol ID
- CA180-291
- Status last verified
- Oct 2013
- First submitted
- 24 Aug 2010
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Second Generation TYROSINE KINASE INHIBITORS (2G TKI) Post Imatinib Failure: Factors Predicting Response and Predictive Value of Response
- ClinicalTrials.gov ID
- NCT01188278
- Acronym / sponsor ID
- CA180-291
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Aug 2010 (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 determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR).
Detailed description
Historic cohort prolonged by a 12-month follow-up period.
Prospective: look forward using periodic observations collected predominantly following subject enrollment: one year of follow up of patients with CP-CML alive at the time of the study.
Retrospective: look back using observations collected predominantly prior to subject selection and enrollment : historical data of patients with CP-CML initiated with a 2G TKIs post-imatinib failure (resistance or intolerance) between 1-Jan-2005 and 30-June-2009.
The inclusion of a historical cohort will allow a rapid enrollment of a large number of patients of this rare pathology, while the prospective follow up of this cohort would allow long term data to be obtained, including the assessment of the impact on survival and appreciate the patient's quality of life (QoL), compliance and satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in CP-CML treated with 2G TKI | – | Drug: ImatinibPatients in CP-CML treated with 2G TKI (nilotinib or dasatinib) post imatinib failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hematology centers (hospitals) which have necessary historical data available
Key inclusion criteria (4 listed)
- Patients diagnosed with CP-CML. (ACA) are allowed
- Age >18 years old
- Prior treatment with imatinib monotherapy as first line treatment, to which the patient is deemed resistant or intolerant.Patients treated by INF and/or AraC prior (but not concomitant) to imatinib are eligible.
- Initiated with a 2G TKIs post-imatinib failure (resistance or intolerance) between 1-Jan-2005 and 30-Jun-2009.
Key exclusion criteria (6 listed)
- Patients in (or with history of) accelerated or blastic phase CML
- Patients treated by allogeneic stem cell transplantation.
- Any other CML treatment except for INF and/or AraC,and a short period of Hydroxyurea or Anagrelide prior to imatinib.
- Patients treated with 2G TKI for reasons other than imatinib failure.
- Patients with no historical data (e.g. possibility of Sokal Score calculation) available.
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 |
|---|---|---|
| ImatinibAlso: Dasatinib, NilotinobDrug being observed but not provided | Drug | Patients in CP-CML treated with 2G TKI |
Primary outcome
Predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR)
Time frame: CCyR at 6 month of 2GTKI treatment
The purpose of this study is to determine predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR), as assessed by the following: * Distribution of patients according to Hammersmith score levels * Characterization of association between Hammersmith score and occurrence of CCyR * Assessment of capacity of Hammersmith score to predict CCyR, using diagnostic test assessment methods. This score is measured at the time of imatinib failure.
5 secondary outcomes
Predictive value of Hammersmith score on Major Molecular Response (MMR)
Time frame: MMR at 3 month of 2GTKI treatment
Predictive factors of Overall survival (including Hammersmith score, MMR at 3 months and CCyR at 6 months of 2G TKI treatment together with patients, disease and treatment characteristics)
Time frame: From switch to 2G TKI between 01Jan2005 and 30Jun2009 to 31Oct2011 if alive or to the death
Predictive value of Hammersmith score compared to other factors
Time frame: From switch to 2G TKI between 01Jan2005 and 30Jun2009 to 31Oct2011 if alive or to the death
Patients populations (socio-demographic data, medical history, disease history, co morbidities treated with 2G TKI
Time frame: When occurs the switch from Imatinib to 2G TKI between 01Jan2005 and 30Jun2009
Patients' satisfaction, Quality of life & compliance to treatment in patients treated with 2G TKIs
Time frame: For all alive patients treated with 2G TKI during the enrolment period (Jun2010 to Oct2010)
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 30 Sep 2016.
- For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.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 Leukemia, Myeloid, Chronic-Phase (CML-CP), 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 4 inclusion and 6 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 30 Sep 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?
Predictive value of Hammersmith score on Complete Cytogenetic Response (CCyR) (time frame: CCyR at 6 month of 2GTKI treatment). 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 30 Sep 2016.