Myelogenous Leukemia, Chronic, Chronic PhasePhase 2NCT01887561
Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial
A Phase 2 study testing dasatinib in people with Myelogenous Leukemia, Chronic, Chronic Phase, run by Kanto CML Study Group at 1 site in Japan.
Trial summary
The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission(CMR) while on dasatinib. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myelogenous Leukemia, Chronic, Chronic Phase
- What is being tested?
- dasatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2012to Dec 2012
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
- 15 years old over.
- ECOG performance status (PS) score 0-2.
- 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.
- female patient who there is not intention with an appropriate sterilization, or cannot use it during a study entry period
- 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 have a Congestive heart failure within 3 months 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
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
National Disaster Medical Center
Tachikawa, Tokyo, 190-0014
Naoki Takesako, +81(0) 42-526-5511, ntakezak@tdmc.hosp.go.jp
About this study
Official title: PhaseⅡClinical Trial of Dasatinib for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase and Stop Therapy After Achieving Complete Molecular Response for Cure D-NewS
The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission(CMR) while on dasatinib.
- Being tested
- dasatinib
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
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 |
|---|---|---|
| treatment | No intervention | Not described Receives: Drug: dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
Measured: by 12 months
Secondary outcomes (8)
'Dasatinib affects immunological responses, as measured by flow cytometry
Measured: at 3,6,12,24 months
Major Molecular Response(MMR) rate measured by RQ-PCR
Measured: by 1 months, then every 6 months for 2 years
Complete Cytogenetic Response (CCyR) rate
Measured: by 6,12 months
Progression free survival (PFS)
Measured: Participants were followed for at least 2 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Participants were followed for at least 2 years
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
Measured: by 3,6 months
Molecular remission rate measured by PQ-PCR after dasatinib re-challenge in cases of molecular relapse
Measured: by 12 months after molecular relapse
Complete Molecular Response(CMR) rate measured by RQ-PCR
Measured: by 1 months, then every 6 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelogenous Leukemia, Chronic, Chronic PhaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanto CML Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naoki Takezako, M.D., Ph.D., Kanto CML Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887561
- Sponsor's protocol ID
- KCSG-04
- Status last verified
- Jun 2013
- First submitted
- 11 Apr 2013
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhaseⅡClinical Trial of Dasatinib for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase and Stop Therapy After Achieving Complete Molecular Response for Cure D-NewS
- ClinicalTrials.gov ID
- NCT01887561
- Acronym / sponsor ID
- KCSG-04
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kanto CML Study GroupUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- First posted
- 27 Jun 2013 (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 assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission(CMR) while on dasatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | No intervention | Drug: dasatinib |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
- 15 years old over.
- ECOG performance status (PS) score 0-2.
- Adequate organ function (hepatic, renal and lung).
- Signed written informed consent.
Key exclusion criteria (5 listed)
- A case with the double cancer of the activity.
- Women who are pregnant or breastfeeding.
- female patient who there is not intention with an appropriate sterilization, or cannot use it during a study entry period
- 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 have a Congestive heart failure within 3 months 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
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 | treatment |
Primary outcome
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
Time frame: by 12 months
8 secondary outcomes
'Dasatinib affects immunological responses, as measured by flow cytometry
Time frame: at 3,6,12,24 months
Major Molecular Response(MMR) rate measured by RQ-PCR
Time frame: by 1 months, then every 6 months for 2 years
Complete Cytogenetic Response (CCyR) rate
Time frame: by 6,12 months
Progression free survival (PFS)
Time frame: Participants were followed for at least 2 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Participants were followed for at least 2 years
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
Time frame: by 3,6 months
Molecular remission rate measured by PQ-PCR after dasatinib re-challenge in cases of molecular relapse
Time frame: by 12 months after molecular relapse
Complete Molecular Response(CMR) rate measured by RQ-PCR
Time frame: by 1 months, then every 6 months for 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
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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.
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 Myelogenous Leukemia, Chronic, Chronic Phase, 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Jun 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR (time frame: by 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 27 Jun 2013.