Leukemia, Myelogenous, Chronic, BCR-ABL PositiveNCT02389972
Effectiveness of Dasatinib in Adult Patients With Chronic Myeloid Leukemia in China: A Multicenter, Registry Study
An observational study of Leukemia, Myelogenous, Chronic, BCR-ABL Positive, run by Bristol-Myers Squibb at 1 site in China.
Trial summary
The primary objective is to describe the effectiveness of dasatinib (Sprycel®) in CML patients in China in the real-world clinical practice setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- What is being tested?
- Dasatinib
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2013to 13 Jul 2017
- 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: Patients must be naive to dasatinib before the enrollment period, be over the age of 18 years with a confirmed diagnosis of any phase CML by the treating physician, and are to initiate treatment with dasatinib based on the physician's clinical judgement
Who may be able to join
- Because this is a product registry study, it will include adult CML patients in any phase treated with dasatinib in China if they meet the following criteria:
- Willing and able to provide written informed consent
- ≥18 years of age
- Confirmed diagnosis of CML patients by attending physician
- Naive to dasatinib before enrollment in study treatment or have received <3 months of dasatinib treatment
- Plan to or are receiving dasatinib therapy based on physician's clinical judgment
- Administered dasatinib after imatinib-resistance or intolerance
Who cannot join
- Patients participating in clinical trials for CML that explicitly prohibit recruitment in additional studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Dasatinib(Sprycel®) in Adult Patients With Chronic Myeloid Leukemia in China: A Multicenter, Registry Study
The primary objective is to describe the effectiveness of dasatinib (Sprycel®) in CML patients in China in the real-world clinical practice setting.
Read the detailed description
Breakpoint cluster region (BCR)
Abelson murine leukemia viral oncogene homolog 1 (c-ABL)
Chronic myeloid leukemia (CML)
- Being tested
- Dasatinib
- 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.
DasatinibDrug
Also called Sprycel
| Study group | Role | What they receive |
|---|---|---|
| CML patients treated with dasatinib | Cohort of chronic myeloid leukemia patients treated with second-line dasatinib (Sprycel) Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Hematologic response (HR) for Chronic phase (CP), Advanced phase (AP),Blast phase (BP)
Hematological Response is a normalization of the blood counts, particularly white blood cell counts. This is the first noticeable indicator that treatment is beginning to work, though not necessarily in the bone marrow
Measured: Upto 2 years
Rate of Cytogenetic response (CR) for Chronic phase, Advanced phase,Blast phase
Cytogenetic Response is a response to treatment of CML that occurs in the marrow, rather than just in the blood
Measured: Upto 2 years
Rate of Molecular response (MR) for Chronic phase,Advanced phase,Blast phase
Molecular response is defined as no detectable BCR-ABL observed through Quantitative polymerase chain reaction (Q-PCR) (International Scale) using an assay with a sensitivity of at least 4.5 logs below the standardized baseline
Measured: Upto 2 years
Secondary outcomes (6)
Demographic and baseline characteristics of patients using dasatinib including health insurance, concomitant regimens, risk scores, and comorbidities based on patient-reported questionnaire
Type and percentage of each variable: health insurance, concomitant regimens and comorbidities; patients distribution by Sokal score
Measured: Upto 2 years
Dasatinib treatment pattern, including medication adherence and treatment interruption based on patient-reported questionnaire
Dasatinib starting dose and administration schedule, cumulative dose, maximum daily dose and duration of exposure; dose alterations (including changes in frequency, reductions and or delays) and reason(s) for dose alterations; discontinuation and reason(s) for dasatinib discontinuation
Measured: Upto 2 years
Relationship between time to initiation of dasatinib after imatinib failure and best response to dasatinib
Measured: Upto 2 years
Progression-free survival (PFS)
Measured: Upto 2 years
Overall survival (OS)
Measured: Upto 2 years
Safety of dasatinib measured by incidence and severity of adverse events
Measured: Upto 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start11 Apr 2013
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myelogenous, Chronic, BCR-ABL PositiveStudies 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
- 128 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
- NCT02389972
- Sponsor's protocol ID
- CA180-518
- Status last verified
- Sep 2017
- First submitted
- 29 Oct 2014
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dasatinib(Sprycel®) in Adult Patients With Chronic Myeloid Leukemia in China: A Multicenter, Registry Study
- ClinicalTrials.gov ID
- NCT02389972
- Acronym / sponsor ID
- CA180-518
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2013 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 17 Mar 2015 (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 primary objective is to describe the effectiveness of dasatinib (Sprycel®) in CML patients in China in the real-world clinical practice setting.
Detailed description
Breakpoint cluster region (BCR)
Abelson murine leukemia viral oncogene homolog 1 (c-ABL)
Chronic myeloid leukemia (CML)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CML patients treated with dasatinib | – | Drug: DasatinibCohort of chronic myeloid leukemia patients treated with second-line dasatinib (Sprycel) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must be naive to dasatinib before the enrollment period, be over the age of 18 years with a confirmed diagnosis of any phase CML by the treating physician, and are to initiate treatment with dasatinib based on the physician's clinical judgement
Key inclusion criteria (7 listed)
- Because this is a product registry study, it will include adult CML patients in any phase treated with dasatinib in China if they meet the following criteria:
- Willing and able to provide written informed consent
- ≥18 years of age
- Confirmed diagnosis of CML patients by attending physician
- Naive to dasatinib before enrollment in study treatment or have received <3 months of dasatinib treatment
Key exclusion criteria (1 listed)
- Patients participating in clinical trials for CML that explicitly prohibit recruitment in additional studies
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 |
|---|---|---|
| DasatinibAlso: Sprycel | Drug | CML patients treated with dasatinib |
Primary outcome
Rate of Hematologic response (HR) for Chronic phase (CP), Advanced phase (AP),Blast phase (BP)
Time frame: Upto 2 years
Hematological Response is a normalization of the blood counts, particularly white blood cell counts. This is the first noticeable indicator that treatment is beginning to work, though not necessarily in the bone marrow
Rate of Cytogenetic response (CR) for Chronic phase, Advanced phase,Blast phase
Time frame: Upto 2 years
Cytogenetic Response is a response to treatment of CML that occurs in the marrow, rather than just in the blood
Rate of Molecular response (MR) for Chronic phase,Advanced phase,Blast phase
Time frame: Upto 2 years
Molecular response is defined as no detectable BCR-ABL observed through Quantitative polymerase chain reaction (Q-PCR) (International Scale) using an assay with a sensitivity of at least 4.5 logs below the standardized baseline
6 secondary outcomes
Demographic and baseline characteristics of patients using dasatinib including health insurance, concomitant regimens, risk scores, and comorbidities based on patient-reported questionnaire
Time frame: Upto 2 years
Dasatinib treatment pattern, including medication adherence and treatment interruption based on patient-reported questionnaire
Time frame: Upto 2 years
Relationship between time to initiation of dasatinib after imatinib failure and best response to dasatinib
Time frame: Upto 2 years
Progression-free survival (PFS)
Time frame: Upto 2 years
Overall survival (OS)
Time frame: Upto 2 years
Safety of dasatinib measured by incidence and severity of adverse events
Time frame: Upto 2 years
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 Sep 2017.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myelogenous, Chronic, BCR-ABL Positive, run by Bristol-Myers Squibb at 1 site in China.
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 7 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: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 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?
Rate of Hematologic response (HR) for Chronic phase (CP), Advanced phase (AP),Blast phase (BP) (time frame: Upto 2 years). 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 Sep 2017.