Chronic Myeloid LeukemiaPhase 2NCT01627132
Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
A Phase 2 study testing Dasatinib in people with Chronic Myeloid Leukemia, run by Shimousa Hematology 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 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
- 50 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2012to Jan 2019
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic Myeloid Leukemia in the Chronic Phase.
- Patients with BCR-ABL-negative checks.
- 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.
- Patients with complications or a history of severe.
- Patients with mutation of T315I、F317L、V299L.
- Patients with additional chromosome abnormalities.
- The case of Pleural effusion with poor control.
- Patients with a history of hematopoietic stem cell transplantation.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Nippon Medical School
Sendagi 1-1-5, Bunkyo-ku,Tokyo, 113-8603
Koiti Inokuchi, MD,PhD, +81(0)3-3822-2131, inokuchi@nms.ac.jp
Hisashi Wakita, MD,PhD, +81(0)476-22-2311, wakita@naritasekijuji.jp
About this study
Official title: Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
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.
- Conditions
- Chronic Myeloid Leukemia
- 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 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.
The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.
Measured: at 12 months
Secondary outcomes (1)
Rate of complete molecular remission that will be sustained after dasatinib rechallenge.
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 posted25 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2017 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shimousa Hematology Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Epidemiological and Clinical Research Information Network
- Responsible party
- Principal investigator, Koiti Inokuchi,MD,PhD., Shimousa Hematology Study Group
- Investigators
- Koiti Inokuchi, Principal investigator, Nippon Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627132
- Sponsor's protocol ID
- SHSG-01
- Status last verified
- Jun 2012
- First submitted
- 14 Feb 2012
- Last updated
- 25 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kumagai T, Nakaseko C, Nishiwaki K, Yoshida C, Ohashi K, Takezako N, Takano H, Kouzai Y, Murase T, Matsue K, Morita S, Sakamoto J, Wakita H, Sakamaki H, Inokuchi K; Kanto CML, Shimousa Hematology Study Groups. Silent NK/T cell reactions to dasatinib during sustained deep molecular response before cessation are associated with longer treatment-free remission. Cancer Sci. 2020 Aug;111(8):2923-2934. doi: 10.1111/cas.14518. Epub 2020 Jun 26.
PubMed 32614159
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial
- ClinicalTrials.gov ID
- NCT01627132
- Acronym / sponsor ID
- SHSG-01
- Conditions
- Chronic Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shimousa Hematology Study GroupUniversity, hospital or other
- Collaborators
- Epidemiological and Clinical Research Information Network
- Study start
- Feb 2012
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 25 Jun 2012 (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
- 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
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic Myeloid Leukemia in the Chronic Phase.
- Patients with BCR-ABL-negative checks.
- 15 years old over.
- ECOG performance status (PS) score 0-2.
- Adequate organ function (hepatic, renal and lung).
Key exclusion criteria (7 listed)
- A case with the double cancer of the activity.
- Women who are pregnant or breastfeeding.
- Patients with complications or a history of severe.
- Patients with mutation of T315I、F317L、V299L.
- Patients with additional chromosome abnormalities.
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
The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib.
Time frame: at 12 months
1 secondary outcome
Rate of complete molecular remission that will be sustained after dasatinib rechallenge.
Time frame: at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
- Derived from this study: PubMed 32614159Kumagai T, Nakaseko C, Nishiwaki K, Yoshida C, Ohashi K, Takezako N, Takano H, Kouzai Y, Murase T, Matsue K, Morita S, Sakamoto J, Wakita H, Sakamaki H, Inokuchi K; Kanto CML, Shimousa Hematology Study Groups. Silent NK/T cell reactions to dasatinib during sustained deep molecular response before cessation are associated with longer treatment-free remission. Cancer Sci. 2020 Aug;111(8):2923-2934. doi: 10.1111/cas.14518. Epub 2020 Jun 26.
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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.
Koiti Inokuchi principal investigator
Nippon Medical School
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 Shimousa Hematology 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 7 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 25 Jun 2012. 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?
Contact Koiti Inokuchi, MD,PhD (+81(0)3-3822-2131, inokuchi@nms.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall probability of maintenance of complete molecular remission at 12 months after stopping 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?
On the ClinicalTrials.gov record for NCT01627132, which also lists 1 linked publication.
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 25 Jun 2012; AzTrials last refreshed its copy on 8 Nov 2026.