LeukemiaPASSNCT02546791
Frequency and Severity of Pleural Effusion Associated With the Use of Dasatinib in Patients With Chronic Myeloid Leukemia. A Descriptive, Mexican Multicenter Study
An observational study of Leukemia, run by Bristol-Myers Squibb.
Trial summary
This is a retrospective, multicenter, descriptive analysis of patients with a diagnosis of chronic myeloid leukemia, treated with dasatinib for at least 45 days. The study will include 100 patients treated in different public centers in the Mexican Republic. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Dasatinib
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2015to 29 Mar 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Public centers in the Mexican Republic
Who may be able to join
- Men and women ≥15 years of age
- Diagnosis of chronic myeloid leukemia in any phase that used dasatinib at any time between January 2008 and November 2014
- Have received dasatinib as part of their first-line or second-line treatment for at least 45 days
Who cannot join
- Patients who received dasatinib as part of any clinical trial
- Patients who do not have complete data on the data collection sheet
- Patients who do not have medical records available at the moment of the data verification
About this study
This is a retrospective, multicenter, descriptive analysis of patients with a diagnosis of chronic myeloid leukemia, treated with dasatinib for at least 45 days. The study will include 100 patients treated in different public centers in the Mexican Republic.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Chronic myeloid leukemia patients treated with Dasatinib | patients with a diagnosis of chronic myeloid leukemia treated with Dasatinib for at least 45 days Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect the absence and presence of pleural effusion in Mexican patients measured from the medical records and databases of each of the participating medical centers
Measured: 1 year and 4 month of data collection
Secondary outcomes (2)
Establish the factors associated with response of the patients who develop pleural effusion
Factors:
Hematological Response
- Standardization of counts in peripheral blood with leukocytes <10 × 10^9 and platelets <450 ×10^9
- Absence of immature elements in the smear
- Basophils <5%
- Absence of palpable splenomegaly
Complete Molecular Response (CMR)
Undetectable BCR-ABL mRNA transcripts by real time quantitative and/or nested Partial Cytogenetic Response (PCR) in two consecutive blood samples of adequate quality (sensitivity >104) Major Molecular Response (MMR)
Ratio of BCR-ABL to ABL (or other housekeeping genes) ≤0.1% on the international scale
Measured: 1 year and 4 month of data collection
Main characteristics of the patients who develop pleural effusion
Characteristics: Age, gender, comorbidity
Measured: 1 year and 4 month of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study start22 Jul 2015
- Primary completion30 Nov 2016
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 101 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
- NCT02546791
- Sponsor's protocol ID
- CA180-556
- Acronym
- PASS
- Status last verified
- Jul 2017
- First submitted
- 9 Sep 2015
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Severity of Pleural Effusion Associated With the Use of Dasatinib in Patients With Chronic Myeloid Leukemia. A Descriptive, Mexican Multicenter Study
- ClinicalTrials.gov ID
- NCT02546791
- Acronym / sponsor ID
- PASS / CA180-556
- Conditions
- Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2015 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 11 Sep 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.
This is a retrospective, multicenter, descriptive analysis of patients with a diagnosis of chronic myeloid leukemia, treated with dasatinib for at least 45 days. The study will include 100 patients treated in different public centers in the Mexican Republic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic myeloid leukemia patients treated with Dasatinib | – | Drug: Dasatinibpatients with a diagnosis of chronic myeloid leukemia treated with Dasatinib for at least 45 days |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Public centers in the Mexican Republic
Key inclusion criteria (3 listed)
- Men and women ≥15 years of age
- Diagnosis of chronic myeloid leukemia in any phase that used dasatinib at any time between January 2008 and November 2014
- Have received dasatinib as part of their first-line or second-line treatment for at least 45 days
Key exclusion criteria (3 listed)
- Patients who received dasatinib as part of any clinical trial
- Patients who do not have complete data on the data collection sheet
- Patients who do not have medical records available at the moment of the data verification
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 |
|---|---|---|
| Dasatinib | Drug | Chronic myeloid leukemia patients treated with Dasatinib |
Primary outcome
Detect the absence and presence of pleural effusion in Mexican patients measured from the medical records and databases of each of the participating medical centers
Time frame: 1 year and 4 month of data collection
2 secondary outcomes
Establish the factors associated with response of the patients who develop pleural effusion
Time frame: 1 year and 4 month of data collection
Main characteristics of the patients who develop pleural effusion
Time frame: 1 year and 4 month of data collection
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 26 Jul 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
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 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 26 Jul 2017. 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?
Detect the absence and presence of pleural effusion in Mexican patients measured from the medical records and databases of each of the participating medical centers (time frame: 1 year and 4 month of data collection). 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 26 Jul 2017.