Chronic Myeloid LeukemiaNCT03509896
Study of Chinese Newly Diagnosed Participants With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
An observational study of Chronic Myeloid Leukemia and Philadelphia Chromosome, run by Bristol-Myers Squibb at 1 site in China.
Trial summary
Observational medical record review of newly diagnosed CML-CP participants in China Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Philadelphia Chromosome, Chronic Myeloid Leukemia in Chronic Phase
- What is being tested?
- Non-Interventional
- How many people
- 463 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2017to 28 Sep 2019
- 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: Multi-center, observational, medical record review of approximately 1000 newly diagnosed CML-CP patients in China
Who may be able to join
- Ph+ CML-CP patients who were diagnosed between August 1, 2014 to August 1, 2016
- 18 years or older at time of diagnosis
Who cannot join
- Participants once enrolled in any interventional clinical trial for CML
- Participants whose records are not available
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Pattern, Clinical Outcome and Healthcare Resource Utilization Associated With Chinese Newly Diagnosed Patients With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP): A Retrospective Observational Study
Observational medical record review of newly diagnosed CML-CP participants in China
- Conditions
- Chronic Myeloid Leukemia, Philadelphia Chromosome, Chronic Myeloid Leukemia in Chronic Phase
- Being tested
- Non-Interventional
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Philadelphia Chromosome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Participants newly diagnosed with CML-CP | Not described Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants receiving each first-line treatment option
Measured: 2 years
Number of participants with complete cytogenetic response
Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow (BM)
Measured: 2 years
Number of participants with major molecular response (MMR)
Major molecular response (MMR) is defined as 3-log reduction in International Scale of BCR-ABL mRNA
Measured: 2 years
Number of participants of each initial dose schema
Measured: 2 years
Starting dose of each first-line agent
Measured: 2 years
Secondary outcomes (2)
Distribution of demographic characteristics
Including age, sex, height, weight
Measured: 2 years
Distribution of clinical characteristics
Including health insurance and comorbid conditions
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start30 Nov 2017
- Primary completion7 Jun 2019
- Study completion28 Sep 2019
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
- 463 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
- NCT03509896
- Sponsor's protocol ID
- CA180-681
- Status last verified
- Jun 2022
- First submitted
- 18 Apr 2018
- Last updated
- 27 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Pattern, Clinical Outcome and Healthcare Resource Utilization Associated With Chinese Newly Diagnosed Patients With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP): A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT03509896
- Acronym / sponsor ID
- CA180-681
- Conditions
- Chronic Myeloid Leukemia, Philadelphia Chromosome, Chronic Myeloid Leukemia in Chronic Phase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 28 Sep 2019 (actual)
- First posted
- 26 Apr 2018 (actual)
- 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.
Observational medical record review of newly diagnosed CML-CP participants in China
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants newly diagnosed with CML-CP | – | Other: Non-Interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multi-center, observational, medical record review of approximately 1000 newly diagnosed CML-CP patients in China
Key inclusion criteria (2 listed)
- Ph+ CML-CP patients who were diagnosed between August 1, 2014 to August 1, 2016
- 18 years or older at time of diagnosis
Key exclusion criteria (3 listed)
- Participants once enrolled in any interventional clinical trial for CML
- Participants whose records are not available
- Other protocol defined inclusion/exclusion criteria could apply
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 |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Participants newly diagnosed with CML-CP |
Primary outcome
Number of participants receiving each first-line treatment option
Time frame: 2 years
Number of participants with complete cytogenetic response
Time frame: 2 years
Complete Cytogenetic Response (CCyR): 0% Ph+ cells in metaphase in bone marrow (BM)
Number of participants with major molecular response (MMR)
Time frame: 2 years
Major molecular response (MMR) is defined as 3-log reduction in International Scale of BCR-ABL mRNA
Number of participants of each initial dose schema
Time frame: 2 years
Starting dose of each first-line agent
Time frame: 2 years
2 secondary outcomes
Distribution of demographic characteristics
Time frame: 2 years
Distribution of clinical characteristics
Time frame: 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 27 Jun 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink 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
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 Chronic Myeloid Leukemia and Philadelphia Chromosome, 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 2 inclusion and 3 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 27 Jun 2022. 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?
Number of participants receiving each first-line treatment option (time frame: 2 years). The study lists 5 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 27 Jun 2022.