Chronic Myeloid LeukemiaPhase 2CMR-CMLNCT01342679
A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib
A Phase 2 study testing dasatinib in people with Chronic Myeloid Leukemia, run by Kanto CML Study Group at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- dasatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2011to Sep 2014
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Myeloid Leukemia in the Chronic Phase
- 20 years old over
- ECOG performance status (PS) score 0-2
- Patients for major molecular response (MMR) with no CMR
- Adequate organ function (hepatic, renal and lung)
- Signed written informed consent
Who cannot join
- A case with the double cancer of the activity
- Women who are pregnant or breastfeeding
- The case of Pleural effusion clearly
- Patients with complications or a history of severe or uncontrolled cardiovascular failure following
- have a Myocardial infarction within 6 months
- have an Angina within 3 months
Show all 12Show fewer
- have a Congestive heart failure within 3 months
- have a suspected congenital QT syndrome
- have a QTc interval of more than 450msec at baseline
- A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
- Prior treatment with dasatinib
- Subjects with T315I, F317L and V299L BCR-ABL point mutations
Trial locations and contacts
1 site in 1 country.
Japan1 site
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677
About this study
The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- dasatinib
- Keywords
- chronic myeloid leukemia, dasatinib, complete molecular response
- 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 BMS-354825
100mg QD
| Study group | Role | What they receive |
|---|---|---|
| dasatinib | Experimental | Not described Receives: Drug: dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete molecular response (CMR) after treatment with dasatinib
Measured: at 12 months
Secondary outcomes (4)
Dasatinib of dose intensity
Measured: at 12 months
Expansions rate of large granular lymphocyte
Measured: at 12 months
Progression free survival
Measured: at 12 months
Number of Participants with Adverse Events
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2013
- Study completionSep 2014
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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanto CML Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Epidemiological and Clinical Research Information Network
- Investigators
- Chikashi Yoshida, MD, PhD, Principal investigator, National Hospital Organization, Mito Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342679
- Sponsor's protocol ID
- KCSG-02
- Acronym
- CMR-CML
- Status last verified
- Apr 2011
- First submitted
- 25 Apr 2011
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib
- ClinicalTrials.gov ID
- NCT01342679
- Acronym / sponsor ID
- CMR-CML / KCSG-02
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- chronic myeloid leukemia, dasatinib, complete molecular response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kanto CML Study GroupUniversity, hospital or other
- Collaborators
- Epidemiological and Clinical Research Information Network
- Study start
- Apr 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Apr 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 complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dasatinib | Experimental | Drug: dasatinib |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic Myeloid Leukemia in the Chronic Phase
- 20 years old over
- ECOG performance status (PS) score 0-2
- Patients for major molecular response (MMR) with no CMR
- Adequate organ function (hepatic, renal and lung)
Key exclusion criteria (12 listed)
- A case with the double cancer of the activity
- Women who are pregnant or breastfeeding
- The case of Pleural effusion clearly
- Patients with complications or a history of severe or uncontrolled cardiovascular failure following
- A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
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: BMS-354825100mg QD | Drug | dasatinib |
Primary outcome
Rate of complete molecular response (CMR) after treatment with dasatinib
Time frame: at 12 months
4 secondary outcomes
Dasatinib of dose intensity
Time frame: at 12 months
Expansions rate of large granular lymphocyte
Time frame: at 12 months
Progression free survival
Time frame: at 12 months
Number of Participants with Adverse Events
Time frame: at 12 months
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 15 Sep 2015.
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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.
Chikashi Yoshida, MD, PhD principal investigator
National Hospital Organization, Mito Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dasatinib in people with Chronic Myeloid Leukemia, run by Kanto CML Study Group at 1 site in Japan.
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 6 inclusion and 12 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 15 Sep 2015. 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 Japan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 complete molecular response (CMR) after treatment with dasatinib (time frame: at 12 months). 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 15 Sep 2015.